4.5MM TI CURVED BROAD LCP® PLATE 13 HOLES/247MM
Report
- Report Number
- 8030965-2018-57056
- Event Type
- Injury
- Date Received
- October 8, 2018
- Report Date
- September 17, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HRS
- PMA / PMN Number
- K092609
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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. ADDITIONAL DEVICE CODE: HWC, KTT. DATE DEVICE RETURNED TO MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE HAS BEEN 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. IDEVICE HISTORY LOT PART: 426.632. LOT: 2582357. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 16.MAR.2010. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITY NOTED. THIS LOT MET ALL 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. DEVICE HISTORY 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 SUMMARY INVESTIGATION SELECTION: INVESTIGATION SITE: GRENCHEN. SELECTED FLOW(S): 5. BROKEN. VISUAL INSPECTION: THE PLATE IS BROKEN AT THE HOLE 6. 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. THE LASER MARKING IS READABLE, AND THE PLATE WAS RETURNED IN A DIFFERENT PACKAGING FROM THE ORIGINAL ONE. FUNCTIONAL TEST: THE FUNCTIONAL TEST IS NOT REQUIRED PER SELECTED INVESTIGATION WORK FLOW. DOCUMENT/SPECIFICATION REVIEW: A DHR REVIEW WAS PERFORMED FOR THE AFFECTED LOT 2582357 / WORK ORDER (B)(4)/ ARTICLE 426.632. THE INITIAL AND THE FINAL LOT SIZE WAS (B)(4) PARTS. NEITHER ABNORMALITIES, DEVIATIONS OR NCS WERE TRIGGERED WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE MANUFACTURING DRAWING FOR THE PLATE IS DOCUMENTED IN THE DHR MENTIONED ABOVE. 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, EXCEPT FOR THE ONES WHICH WERE UN-MEASURABLE DUE TO THE BREAKAGE POINT. HOWEVER, 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 CAN BE EXCLUDED. MATERIAL OR HARDNESS REVIEW: AS THERE IS NOT HARDNESS TEST DEFINED DURING THE MANUFACTURING PROCESS REGARDING TO TITANIUM PLATES, THEREFORE, THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE RAW MATERIAL USED FULFILLED THE SPECIFICATIONS. SUMMARY: 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 THEIR SPECIFICATIONS. SINCE NO MANUFACTURING ISSUE WAS DETECTED, NO FURTHER ACTIONS HAVE BEEN TAKEN. 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.
FURTHER IT WAS REPORTED THAT ALL SCREWS AND BROKEN PLATE WAS REMOVED ON (B)(6) 2018. ALL FRAGMENTS WERE REMOVED. X-RAY WAS USED DETECT THE BROKEN PLATE. CONCOMITANT DEVICES REPORTED: CORTSCR Ø4.5 SELF-TAP L48 TI (PART: 414.848, LOT: 9956219, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L34 TAN (PART: 413.334, LOT: L105969, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L38 TAN (PART: 413.338, LOT: 9791845, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L38 TAN (PART: 413.338, LOT: L134861, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L38 TAN (PART: 413.338, LOT: L134861, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L40 TAN (PART: 413.340, LOT: 9551134, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L40 TAN (PART: 413.340, LOT: 9478952, QUANTITY 1); LOCKSCR Ø5 SELF-TAP L42 TAN (PART: 413.342, LOT: L120064, QUANTITY: 1); LOCKSCR SELF-TAP TAN (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 3). THIS REPORT IS FOR ONE (1) 4.5MM TI CURVED BROAD LCP PLATE 13 HOLES/247MM.
ADDITIONAL PATIENT IDENTIFIER: (B)(6). THIS REPORT IS FOR AN UNKNOWN LCP BROAD PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT WAS IMPLANTED WITH AN UNKNOWN LOCKING COMPRESSION PLATE (LCP) BROAD PLATE ON UNKNOWN DATE. ON UNKNOWN DATE IT WAS DETERMINED THE PLATE HAD BROKEN. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE THE BROKEN PLATE WAS REMOVED. THIS REPORT IS FOR ONE (1) UNKNOWN LCP BROAD PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785358 | 4.5MM TI CURVED BROAD LCP® PLATE 13 HOLES/247MM | PLATE, FIXATION, BONE | HRS | OBERDORF SYNTHES PRODUKTIONS GMBH | 2582357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |