INSERT FOR FNS INSERTION HANDLE
Report
- Report Number
- 8030965-2019-67938
- Event Type
- Malfunction
- Date Received
- September 3, 2019
- Date of Event
- July 30, 2019
- Report Date
- August 5, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- KTT
- UDI-DI
- 07611819657359
- PMA / PMN Number
- K172872
- 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. H3 (DEVICE EVALUATED BY MFR), H6: INVESTIGATION SUMMARY INVESTIGATION SELECTION. INVESTIGATION SITE: CQ ZUCHWIL . SELECTED FLOW: FUNCTIONAL. WE HAVE RECEIVED THE FOLLOWING PARTS BACK FOR INVESTIGATION: PART 03.168.008; LOT: 170435-108; QTY. 1 - INSERT HANDLE; PART 03.168.009; LOT: 180071-105; QTY. 1 - INS F/INSERTION HANDLE; PART 03.168.013; LOT: 180067-104; QTY. 1 - PROTECTION SLEEVE F/INSERTION INSTR; PART 03.168.011; LOT: F-20966; QTY. 1 - DRILL BIT Ø4.3 L413. VISUAL INSPECTION: THE RECEIVED INSTRUMENTS ARE STILL IN A GOOD CONDITION. ONLY SLIGHT SCRATCHES ARE VISIBLE AT THE INSERTION HANDLE AND PROTECTION SLEEVE. THE CUTTING EDGES OF THE DRILL BIT AT THE TIP SHOW ONLY SLIGHT WEAR SINGS. OTHERWISE, THERE IS NO OTHER NOTABLE DAMAGES VISIBLE. FUNCTIONAL TEST: A FUNCTIONAL TEST TOGETHER WITH PRODUCT DEVELOPMENT (SUSTAINING ENGINEERING) WAS PERFORMED. ANOTHER PLATE WAS AVAILABLE TO REPRODUCE THE COMPLAINED ISSUE. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE DRILL SLEEVE AND AS WELL THE DRILL BIT MET THE PLATE HOLES AS INTENDED. NO MISALIGNMENT OR INTERFERING WITH OTHER DEVICES, LIKE MENTIONED IN THE EVENT DESCRIPTION, COULD BE DETECTED/REPLICATED. SUMMARY: THE COMPLAINT CONDITION COULD NOT BE CONFIRMED DURING THE PERFORMED CQ EVALUATION, AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. IN HINDSIGHT AND WITH THE PROVIDED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE COMPLAINED ISSUE. WE ONLY CAN ASSUME THAT POSSIBLY AN INSUFFICIENT CONNECTION, OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE STEPS, COULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. PLEASE REFER TO THE CURRENT TECHNIQUE GUIDE ¿DSEM/TRM/0614/0098(2) A¿. FINALLY, WE CAN CONFIRM THAT THE CAUSE OF FAILURE IS NOT FROM ANY MANUFACTURING NON-CONFORMANCE. 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. H3 (DEVICE EVALUATED BY MFR), H4 (DEVICE MANUFACTURE DATE), H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT: PART: 03.168.009, LOT: 180071-105, MANUFACTURING SITE: SELZACH, SUPPLIER: LEITNER AG, RELEASE TO WAREHOUSE DATE: 18. OCTOBER 2018. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H11: D4 ( LOT#), D11 (CONCOMITANT MEDICAL PRODUCTS). 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.
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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE INSERTION HANDLE, THE INSERT, THE PROTECTION SLEEVE AND THE DRILL BIT IN QUESTION. WHEN THE SURGEON TRIED TO DRILL, THE DRILL BIT INTERFERED WITH OTHER DEVICES AND IT COULD NOT REACH TO A PLATE. THE SURGEON RE-ATTACHED THE PROTECTION SLEEVE TO THE DRILL BIT AND HE COULD DRILL SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNK - POWERED DRIVERS/HANDPIECES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) INSERT FOR FNS INSERTION HANDLE. THIS REPORT IS 3 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 748221 | INSERT FOR FNS INSERTION HANDLE | APPLIANCE,FIXATION,NAIL | KTT | OBERDORF SYNTHES PRODUKTIONS GMBH | 180071-105 | 07611819657359 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK - PLATES| UNK - POWERED DRIVERS/HANDPIECES |