4.5MM BROAD LCP® PLATE 9 HOLES/170MM
Report
- Report Number
- 8030965-2018-58181
- Event Type
- Injury
- Date Received
- November 13, 2018
- Report Date
- December 3, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- UDI-DI
- 07611819242043
- PMA / PMN Number
- K082807
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- PHYSICIAN
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. 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.
PART: 226.591; LOT: 8097139; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: OCTOBER 17, 2012. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE 15354 WAS REVIEWED AND CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SITE: GRENCHEN; SELECTED FLOW 5: BROKEN VISUAL INVESTIGATION: THE PLATE IS BROKEN AT HOLE 5 (COUNTED FROM THE RIGHT TO THE LEFT SIDE). THE PLATE HAS SEVERAL SCRATCHES ON THE SURFACE. FURTHERMORE, THERE ARE SEVERAL ABRASIONS AND INJURIES ON THE SURFACE WITHIN THE HOLES; ESPECIALLY AROUND THE BREAKAGE POINT. DIMENSIONAL INSPECTION: ALL DIMENSIONS OF THE PLATE RECEIVED WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION WERE MEASURED AND HAVE FULFILLED THEIR SPECIFICATIONS ACCORDING TO THE DRAWING. IN ADDITION, DURING THE MANUFACTURING INVESTIGATION, ALL RELEVANT FEATURES HAVE BEEN INSPECTED AND THEY HAVE PASSED ITS SPECIFICATIONS. DRAWING/SPECIFICATION REVIEW: THE CAUSE OF THE COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED OVERLOAD BREAKAGE/DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. MATERIAL REVIEW: THE MANUFACTURING DOCUMENTS AND THE RAW MATERIAL CERTIFICATE 15354 WERE REVIEWED AND CONFIRMED TO BE CORRECT PER THE SPECIFICATION WITH NO NON-CONFORMANCE NOTED. SUMMARY: THE COMPLAINT IS CONFIRMED AS THE LOCKING COMPRESSION PLATE (LCP) IS BROKEN AS COMPLAINED. AS RELEVANT FOR THE COMPLAINT CONDITION ¿PLATE BROKEN POST-OPERATIVELY,¿ THE FOLLOWING FEATURES HAVE BEEN IDENTIFIED AND MEASURED. ALL DIMENSIONS OF THE PLATE RECEIVED WHICH ARE RELEVANT FOR THE COMPLAINT CONDITION WERE MEASURED AND HAVE FULFILLED THEIR SPECIFICATIONS ACCORDING TO THE DRAWING. IN ADDITION, DURING THE MANUFACTURING INVESTIGATION, ALL RELEVANT FEATURES HAVE BEEN INSPECTED AND THEY HAVE PASSED ITS SPECIFICATIONS. BESIDES, DURING THE MANUFACTURING PROCESS, THE LOT RELATED TO THIS COMPLAINT WAS INSPECTED REGARDING TO ITS DIMENSIONAL FEATURES SUCH AS BALL HEIGHT AND THREAD ZERO POINT THROUGH THE INSPECTION SHEET AND THE WHOLE LOT HAS PASSED ITS SPECIFICATIONS. THEREFORE, THIS PLATE WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND A MANUFACTURING ISSUE HAS BEEN EXCLUDED. THE RECEIVED CONDITION OF THE DEVICE AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE PLATE IS BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW, THIS COMPLAINT IS RATED AS NOT VALID SINCE NO DEVIATIONS WERE FOUND IN THE MANUFACTURING DOCUMENTATION REVIEWED AS WELL AS ALL MEASUREMENTS PERFORMED DURING THIS INVESTIGATION ARE ACCORDING TO SPECIFICATIONS. THUS, ALL RELEVANT MEASUREMENTS PERFORMED ARE ACCORDING TO THEIR SPECIFICATIONS. SINCE NO MANUFACTURING ISSUE WAS DETECTED, NO FURTHER ACTIONS HAVE BEEN TAKEN. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.
IT WAS REPORTED THAT ON OCTOBER 19, 2018 PATIENT UNDERWENT REVISION SURGERY FOR A MIDSHAFT FEMUR FRACTURE A BROAD LOCKING COMPRESSION PLATE (LCP) WAS DISCOVERED TO BE BROKEN. PATIENT WISHED TO LAUNCH A COMPLAINT ABOUT THE PRODUCT CLAIMING IT WAS DEFECTIVE. REVISION SURGERY WAS DONE WITH AN EXPERT ANTEGRADE FEMORAL NAIL. THERE WAS NO SURGICAL DELAY REPORTED HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. REMOVED BROKEN OR DAMAGED DEVICES OR FRAGMENTS EASILY. CONCOMITANT DEVICE REPORTED: LOCKING SCREW Ø5 SELF-TAP L34 SST (PART#: 213.334, LOT#: 8717366, QUANTITY: 1) LOCKING SCREW Ø5 SELF-TAP L32 SST (PART#: 213.332, LOT#: 8430705, QUANTITY: 4) . LOCKING SCREW Ø5 SELF-TAP L32 SST (PART#: 213.332, LOT#: 8717392, QUANTITY: 1) . LOCKING SCREW Ø5 SELF-TAP L32 SST (PART#: 213.332, LOT#: 8911751, QUANTITY: 1) . LOCKING SCREW Ø5 SELF-TAP L30 SST (PART#: 213.330, LOT#: 8604895, QUANTITY: 1).
ADDITIONAL PRODUCT CODES: HWC, KTT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). DEVICE BREAKAGE LED TO MEDICAL DEVICE REMOVAL AND SURGICAL INTERVENTION. 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.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH A LOCKING COMPRESSION PLATE (LCP) BROAD PLATE FOR A MIDSHAFT FEMUR FRACTURE ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS REVEALED THE PLATE WAS BROKEN. PATIENT WAS RETURNED TO SURGERY ON UNKNOWN DATE WHERE THE BROKEN PLATE WAS REMOVED AND PATIENT WAS REVISED TO AN EXPERT ANTEGRADE FEMORAL NAIL. CONCOMITANT DEVICE: LOCKING SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR A 4.5MM BROAD LCP PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 906824 | 4.5MM BROAD LCP® PLATE 9 HOLES/170MM | PLATE, FIXATION, BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH | 8097139 | 07611819242043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Life Threatening |