8.5MM MEDULLARY REAMER HEAD
Report
- Report Number
- 2939274-2018-54377
- Event Type
- Injury
- Date Received
- October 15, 2018
- Report Date
- September 27, 2018
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HTO
- UDI-DI
- 10886982194176
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. ADDITIONAL, POSSIBLE SUPPLIER LOT: 2162802, 2153897 . 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. DHR REVIEW WAS COMPLETED. POSSIBLE SUPPLIER LOT: 2162802, 2153897 , SYNTHES LOT: 5226959 , PART: 352.085 , LOT: 2162802 , MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 06 FEB 2006 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES 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 WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO SPECIFICATION FOR IMPLANTS FOR SURGERY PART: 352.085 , LOT: 2153897 , MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 09. DEC. 2005 . 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 WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO SPECIFICATION FOR IMPLANTS FOR SURGERY 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 CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. INVESTIGATION FLOW: BROKEN VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AT CUSTOMER QUALITY (CQ) CONFIRMED THE CONDITION OF A BROKEN REAMER HEAD, WHICH AGREES WITH THE REPORTED COMPLAINT CONDITION. ONLY APPROXIMATELY HALF OF THE BROKEN REAMER HEAD WAS RETURNED. THE REAMER HEAD BROKE AXIALLY WITH JAGGED EDGES. DHR REVIEW: BASES ON THE DHR REVIEW, THE RETURNED DEVICE WAS EITHER MANUFACTURED IN DECEMBER 2005 OR FEBRUARY 2006 AND IS THEREFORE OVER 12 YEARS OLD. 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. 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. DOCUMENT/SPECIFICATION REVIEW: DESIGN DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: AN ACCURATE MEASUREMENT OF THE OUTSIDE DIAMETER OF THE BROKEN REAMER HEAD COULD NOT BE OBTAINED AT CQ BECAUSE ONLY APPROXIMATELY HALF OF THE BROKEN REAMER HEAD WAS RETURNED. THE INSIDE DIAMETER AT THE DISTAL END MEASURED Ø2.66MM AT CQ (GAUGE PIN) WHICH IS WITHIN SPECIFICATION OF Ø2.7MM +/-0.05MM. RISK DOCUMENTATION: PART NUMBER: 352.XXX COMPLAINT CATEGORY: BROKEN PART FAMILY: 352.085 TO 352.190 [MEDULLARY REAMER HEADS] THE REAMER POWERDRIVEN - CORE DOSSIER DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. THE DOCUMENT ADDRESSES THE HAZARD OF ¿BROKEN DEVICE DURING SURGERY; FRAGMENTS REMAINS ENCLOSED WITH THE PATIENT INTRAOPERATIVELY [SYNTHES : BROKEN : INTRAOPERATIVELY], [SYNTHES : BROKEN : PROCEDURAL STEP UNKNOWN]]¿ UNDER THE FUNCTION ¿INSTRUMENT DESIGNED FOR DURABILITY AND WITHSTANDING FORCES OVER PRODUCT LIFETIME¿ WITH A RESIDUAL RISK LEVEL OF ¿ACCEPT.¿ THIS HAZARD CARRIES A MODERATE SEVERITY OF HARM OF ¿3¿ AND AN UNLIKELY OCCURRENCE OF ¿2¿ WHICH CORRESPONDS TO AN ESTIMATED OCCURRENCE RATE OF > 1:10,000 (0.01%) AND </= 1:1,000 (0.1%). THERE ARE 266 RELEVANT COMPLAINTS FOR THIS DEVICE FAMILY IN THE GLOBAL COMPLAINT HISTORY (SEARCH CRITERIA JANUARY, 2008 TO NOVEMBER, 2018). PER SALES & COMPLAINTS (2013-15) : TF10059 - REAMERS (POWER DRIVEN) A CORRECTION FACTOR OF 29 CAN BE UTILIZED TO ESTIMATE THE DEVICE USAGE OVER THE LIFETIME OF THE PRODUCT. APPROXIMATELY 156,074 DEVICES HAVE BEEN DISTRIBUTED GLOBALLY FOR THE SAME TIME FRAME WHICH RESULTED IN AN ESTIMATED OCCURRENCE RATE OF 0.0059%. THE COMPLAINT IS ADEQUATELY ADDRESSED BY THE RISK ASSESSMENT. MATERIAL ANALYSIS: THE DESIGN SPECIFIED THE REAMER HEAD TO BE MANUFACTURED FROM DIN 6784 MATERIAL. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO SPECIFICATION FOR IMPLANTS FOR SURGERY. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE RETURNED 12+ YEAR OLD REAMER HEAD BREAKING INTRAOPERATIVELY DURING ATTEMPTED REAMER REMOVAL COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. IT IS MOST LIKELY THAT EXCESSIVE OFF-AXIS FORCES CONTRIBUTED. THIS COMPLAINT IS CONFIRMED HOWEVER NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION AND THE COMPLAINT CONDITION IS ADEQUATELY ADDRESSED BY THE RISK ASSESSMENT. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. 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.
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. 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. 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.
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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. 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 A PATIENT UNDERWENT AN INTERMEDULLARY RODDING OF THE TIBIA ON AN UNKNOWN DATE. IT WAS STATED THAT THE END OF THE FLEXIBLE SHAFT WAS TWISTED, A UNIVERSAL CHUCK WITH T-HANDLE IS REPORTED TO BE BROKEN, AND WHILE THE SURGEON WAS REAMING THE TIBIA, THE MEDULLARY REAMER HEAD BROKE WHILE BEING BACKED OUT. NOT ALL FRAGMENTS WERE RETRIEVED. THERE WAS A SURGICAL DELAY OF 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND BACKUP WAS AVAILABLE. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) 8.5MM MEDULLARY REAMER HEAD. THIS IS REPORT 2 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806714 | 8.5MM MEDULLARY REAMER HEAD | REAMER | HTO | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 2162802 | 10886982194176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |