4.3MM THREADED LCP(TM) DRILL GUIDE
Report
- Report Number
- 8030965-2019-69457
- Event Type
- Malfunction
- Date Received
- October 18, 2019
- Date of Event
- October 2, 2019
- Report Date
- October 2, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- FZX
- UDI-DI
- 07611819246607
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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. ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY. INVESTIGATION SITE: CQ ZUCHWIL; DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: THE LCP DRILL SLEEVE WAS RETURNED SHOWING A PORTION OF THE DISTAL THREADED TIP BROKEN OFF. TWO FRAGMENTS WERE RETURNED TOGETHER WITH THE DEVICE. OTHERWISE IS THE DEVICE IN A GOOD CONDITION WITH NO VISIBLE DAMAGES. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING. DOCUMENT/SPECIFICATION REVIEW: THE REVIEW HAS SHOWN THAT WITH 1.4112 STAINLESS STEEL THE CORRECT MATERIAL WAS USED, AND THAT THE HARDNESS WAS WITHIN THE SPECIFICATION OF 595 +80 HV10 FROM DRAWING. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS ONE SECTION OF THE THREADED TIP IS BROKEN OFF. THIS PRODUCTION LOT WAS MANUFACTURED IN JULY 2016 ACCORDING TO THE SPECIFICATION. THE PARTS CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS WITH NO NON-CONFORMITIES REPORTED. THE CORRECT MATERIAL WAS USED, AND THE HARDNESS PARAMETERS WERE WITHIN THE SPECIFICATIONS. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE PROVIDED INFORMATION THE EXACT CAUSE OF THE BREAKAGE CANNOT BE DEFINED, BASED ON THE COMPLAINT DESCRIPTION AND THE DIAGONAL APPEARANCE OF THE FRACTURE FACE WE CAN ONLY ASSUME THAT THE DEVICE WAS EXPOSED TO TOO MUCH LATERAL STRESS WHEN IT BROKE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: PART: 323.042, LOT: L026401, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: JUL 26, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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. 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.
COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT TIBIAL OSTEOTOMY SURGERY FOR PROXIMAL RIGHT TIBIA WITH THE TOMOFIX PLATE AND THE DRILL SLEEVE. WHEN THE SURGEON ATTACHED THE DRILL SLEEVE INTO THE DISTAL THIRD HOLE AND HE MOVED THE DRILL SLEEVE TO CHECK THE CONNECTION, THE TIP OF THE DRILL SLEEVE BROKE. THE SURGEON REMOVED THE FRAGMENT OF THE SLEEVE. THE SURGEON CONFIRMED THAT NO FRAGMENT REMAINED IN THE BODY BY X-RAYS. THE SURGEON COULD ATTACH A DRILL SLEEVE INTO THE SAME HOLE. THE SURGERY WAS DELAYED BY ABOUT TEN (10) MINUTES. BACK-UP DEVICE WAS AVAILABLE FOR USE. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN TOMOFIX PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) 4.3MM THREADED LCP DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1001303 | 4.3MM THREADED LCP(TM) DRILL GUIDE | GUIDE | FZX | OBERDORF SYNTHES PRODUKTIONS GMBH | L026401 | 07611819246607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK - PLATES: TOMOFIX OSTEOTOMY |