RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER
Report
- Report Number
- 8030965-2024-15173
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- November 26, 2024
- Manufacturer
- SYNTHES GMBH
- Product Code
- HSB
- UDI-DI
- 10886982290656
- PMA / PMN Number
- K201346
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: H3, H6: PHOTO INVESTIGATION: THE PHOTO WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER WAS OBSERVED CONNECTED TO INSERTION HANDLE AND THE ROD IS OBSERVED ON THE INSIDE OF THE NAIL. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE IF THE ROD IS STUCK IN THE NAIL SINCE THE INTERACTION OF THE DEVICES CANNOT BE EVALUATED THROUGH A PHOTO OR WITHTHE EVIDENCE PROVIDED. PER THE RFN-ADVANCED RETROGRADE FEMORAL NAILING SYSTEM SURGICAL TECHNIQUE GUIDE. THE USE OF A REAMING ROD CAN FACILITATE REDUCTION, SERVE AS A GUIDE FOR INTRAMEDULLARY REAMERS, AND AID IN KEEPING BONE FRAGMENTS ALIGNED DURING NAIL INSERTION. THE RFN-ADVANCED RETROGRADE FEMORAL NAIL IS CANNULATED AND CAN BE INSERTED OVER REAMING RODS WITH A MAXIMUM DIAMETER OF 3.85 MM AT THE WIDEST POINT, TYPICALLY AT THE BALL TIP. THE USE OF THE REDUCTION FINGER MAY BE APPROPRIATE IN CERTAIN CIRCUMSTANCES TO HELP ACHIEVE ALIGNMENT OF THE PROXIMAL AND DISTAL FRAGMENTS AND GUIDE THE REAMING ROD TO THE PROXIMAL FRAGMENT. INSERT THE REDUCTION INSTRUMENT TO THE DESIRED DEPTH. PASS THE REAMING ROD THROUGH THE CANNULATION OF THE INSTRUMENT. REMOVE THE REDUCTION INSTRUMENT AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 05-AUG-2024, EXPIRATION DATE: 30-JUN-2029, PART NUMBER: 04.233.134S-US, RFN/11MM/340MM STD BEND/ PE INLAY/ STERIL, LOT NUMBER: 27471P2, LOT QUANTITY: 12. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: H3, H4, H6: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THERE WERE NO DAMAGE OR DEFECT WITH THE RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER, THE POLY INLAY WAS OBSERVED CORRECTLY ALIGNED WITH THE HOLES FROM THE PROXIMAL END NAIL. A DIMENSIONAL INSPECTION WAS PERFORMED FOR THE RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER AND MET SPECIFICATIONS. A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO MATING DEVICE WAS NOT RECEIVED TO ASSESS THE INTERACTION BETWEEN THE DEVICES. THE COMPLAINT CONDITION WAS NOT ABLE TO BE REPLICATED. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR): MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 05-AUG-2024 EXPIRATION DATE: 30-JUN-2029 PART NUMBER: 04.233.134S-US, RFN/11MM/340MM STD BEND/ PE INLAY/ STERIL LOT NUMBER: 27471P2 LOT QUANTITY: (B)(4). THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H6: THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H6 COMPONENT CODES: MOST RELEVANT COMPONENT CODE IS G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. H6: THE PHOTO WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS FOR EVALUATION. THE J&J MEDTECH ORTHOPAEDICS TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED PHOTO. VISUAL ANALYSIS OF THE PHOTO REVEALED THAT RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER WAS OBSERVED CONNECTED TO INSERTION HANDLE AND THE ROD IS OBSERVED ON THE INSIDE OF THE NAIL. HOWEVER, IT IS NOT POSSIBLE TO DETERMINE IF THE ROD IS STUCK IN THE NAIL SINCE THE INTERACTION OF THE DEVICES CANNOT BE EVALUATED THROUGH A PHOTO OR WITH THE EVIDENCE PROVIDED. PER THE RFN-ADVANCED RETROGRADE FEMORAL NAILING SYSTEM SURGICAL TECHNIQUE GUIDE SE_820613 REV. AI PAGE 13. THE USE OF A REAMING ROD CAN FACILITATE REDUCTION, SERVE AS A GUIDE FOR INTRAMEDULLARY REAMERS, AND AID IN KEEPING BONE FRAGMENTS ALIGNED DURING NAIL INSERTION. THE RFN-ADVANCED RETROGRADE FEMORAL NAIL IS CANNULATED AND CAN BE INSERTED OVER REAMING RODS WITH A MAXIMUM DIAMETER OF 3.85 MM AT THE WIDEST POINT, TYPICALLY AT THE BALL TIP. THE USE OF THE REDUCTION FINGER MAY BE APPROPRIATE IN CERTAIN CIRCUMSTANCES TO HELP ACHIEVE ALIGNMENT OF THE PROXIMAL AND DISTAL FRAGMENTS AND GUIDE THE REAMING ROD TO THE PROXIMAL FRAGMENT. INSERT THE REDUCTION INSTRUMENT TO THE DESIRED DEPTH. PASS THE REAMING ROD THROUGH THE CANNULATION OF THE INSTRUMENT. REMOVE THE REDUCTION INSTRUMENT. AS THE DEVICE WAS NOT RETURNED, AN AS-RECEIVED CONDITION COULD NOT BE ASSESSED, AND A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE OVERALL COMPLAINT WAS NOT CONFIRMED FOR RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: MANUFACTURING LOCATION: MONUMENT. MANUFACTURING DATE: 05-AUG-2024. EXPIRATION DATE: 30-JUN-2029. PART NUMBER: 04.233.134S-US, RFN/11MM/340MM STD BEND/ PE INLAY/ STERIL. LOT NUMBER: 27471P2. LOT QUANTITY: (B)(4). COMPONENT PART(S) REVIEWED: COMPONENT PARTS WERE NOT REVIEWED AS THE REPORTED COMPLAINT CONDITION DOES NOT INDICATE BREAKAGE OF THE NAIL. THEREFORE, REVIEW OF THE RAW MATERIALS WOULD NOT BE PERTINENT TO THE REPORTED COMPLAINT CONDITION. DEVICE HISTORY REVIEW: THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILIZATION AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT (B)(4). DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL INFORMATION RECEIVED STATES THAT THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A SURGICAL DELAY ESTIMATED TO BE 10 MINUTES.
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A TIBIAL NAIL CASE, AS THE SURGEON FOLLOWED THE STANDARD PROCEDURE, HE OPENED THE TIBIA, REAMED THE CANAL USING A 2.5MM REAMING ROD, AND INSERTED THE NAIL. WHEN THE SURGEON WENT TO REMOVE THE REAMING ROD, IT BECAME STUCK. THE SURGEON TRIED DIFFERENT WAYS TO GET THE REAMING ROD TO COME BACK OUT THROUGH THE NAIL, BUT EVENTUALLY HAD TO REMOVE THE ENTIRE ASSEMBLY, WITH THE NAIL, AND PICK A NEW ONE. THE SURGEON EVENTUALLY HAD TO PUSH THE REAMING ROD OUT THE DISTAL END OF THE NAIL TO GET IT SEPARATED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES/OUTCOME. NO ADDITIONAL INFORMATION PROVIDED FOR REPORTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1988988 | RFNA/ 11MM/ 340MM/ STANDARD BEND/ STER | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | SYNTHES GMBH | 27471P2 | 10886982290656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |