RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA
Report
- Report Number
- 2939274-2018-55179
- Event Type
- Malfunction
- Date Received
- November 30, 2018
- Report Date
- November 12, 2018
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HSB
- UDI-DI
- 10886982271068
- PMA / PMN Number
- K172157
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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. DEVICE HISTORY LOT: PART: 03.033.002 LOT: L750748. MANUFACTURING SITE: HAEGENDORF. RELEASE TO WAREHOUSE DATE: 10. JULY 2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR RELEVANT NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE ONLY LOT TRACKED SUB-COMPONENT IS PART 60077325 (03.010.497) WITH LOT T162120, AS EXACTLY THIS DEVICE IS BROKEN. FURTHER REVIEW HAS SHOWN THAT THE NON-CONFORMITY WAS CREATED AS ONE PIECE OF THIS LOT DID GET DAMAGED ON THE TRANSPORTATION BETWEEN HAEGENDORF AND MONUMENT. THE DAMAGED PIECE HAS BEEN DISCARDED AND THE REMAINING 11 PIECES WERE RE-INSPECTED AND NO DAMAGE WAS DETECTED. THEREFORE IT IS UNLIKELY THAT THIS TRANSPORTATION DAMAGE IS RELEVANT FOR THE COMPLAINT CONDITION. HOWEVER, A FINAL CONCLUSION IS ONLY POSSIBLE AFTER A PHYSICAL EVALUATION OF THE DEVICE. REVIEW FOR PART 60077325 (03.010.497) WITH LOT T162120: PART NUMBER: 03.010.497. SYNTHES LOT NUMBER: T162120. RELEASE TO WAREHOUSE DATE: 12-MAR-2018. MANUFACTURE SITE: TUTTLINGEN. PART EXPIRATION DATE: N/A. LIST OF NONCONFORMANCE¿S: N/A. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. THE NON-CONFORMITY NR-0096204 WAS CREATED AS ONE PIECE OF THIS LOT DID GET DAMAGED ON THE TRANSPORTATION BETWEEN HAEGENDORF AND MONUMENT. DEVICE EVALUATION: UPON VISUAL INSPECTION, IT WAS OBSERVED THAT ONE OF THE CAM LOCK LEVER TAB WAS BROKEN. THE BROKEN PLASTIC PIECE OF THE CAM LOCK TAB WAS STILL ATTACHED TO THE ARM WHILE THE REMAINING BROKEN PIECE WAS MISSING AND NOT RETURNED. THERE ARE MINIMAL SIGNS OF WEAR WITHIN THE HOLES OF THE AIMING ARM. IT IS MORE LIKELY THAT THE DEVICE WAS SUBJECT TO UNINTENDED FORCES DURING DISTRIBUTION OR STORAGE/HANDLING. OVERALL, THE AIMING ARM WAS IN GOOD CONDITION AND NO NEW ISSUES WERE IDENTIFIED DURING INVESTIGATION. NO SURFACE WEAR WAS NOTED, CONSISTENT WITH THE LACK OF USAGE OF THE DEVICE. THE RECEIVED CONDITION AGREES WITH THE COMPLAINT DESCRIPTION, THEREFORE, THE COMPLAINT HAS BEEN CONFIRMED. DOCUMENT/SPECIFICATION REVIEW: REVIEW OF THE DEVICE HISTORY RECORD FOR THE RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FURTHER REVIEW HAS SHOWN THAT THE NON-CONFORMITY WAS CREATED AS ONE PIECE OF THIS LOT DID GET DAMAGED ON THE TRANSPORTATION BETWEEN HAEGENDORF AND MONUMENT. HOWEVER, THIS NON-CONFORMANCE IS NOT RELEVANT TO THE THIS COMPLAINT, AS THE ALL OF THE PIECES WERE RE-INSPECTED AND THAT THE ONE DAMAGED PIECE WAS DISCARDED. THE REMAINING WERE FOUND TO BE CONFIRMING AND NO DAMAGES WERE DETECTED. THEREFORE IT IS UNLIKELY THAT THIS TRANSPORTATION DAMAGE IS RELEVANT FOR THE COMPLAINT CONDITION. REVIEW OF THE SUB-COMPONENT DEVICE HISTORY RECORD FOR THE CAM LOCK FOR RADIOLUCENT AIMING ARM SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE AND IT'S SUB COMPONENTS THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. MATERIAL/HARDNESS REVIEW: THE RAW MATERIAL CERTIFICATE FOR THE CAM LOCK SUB-COMPONENT WAS REVIEWED. THE USED MATERIAL WAS ACCORDING TO THE SPECIFICATION OF THE DEVICE. NO NCRS WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. DIMENSIONAL ANALYSIS: THE BROKEN PIECE OF THE CAM LOCK TAB WAS RETAINED WITHIN THE AIMING ARM COMPONENT. DUE TO THE NATURE OF THE BREAKAGE, IT WAS INACCESSIBLE TO TAKE MEASUREMENTS AROUND THE BROKEN PART OF THE CAM LOCK TABS.THEREFORE DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED. CONCLUSION: DURING THE INVESTIGATION NO UNIDENTIFIED ISSUES WERE FOUND. THE OVERALL COMPLAINT CONDITION IS CONFIRMED; HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES WERE IDENTIFIED DURING THIS INVESTIGATION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES DURING DISTRIBUTION OR STORAGE/HANDLING. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. INITIAL REPORTER IS SYNTHES SALES CONSULTANT. DHR REVIEW WAS COMPLETED. PART: 03.033.002. LOT: L750748. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: (B)(6) 2018. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 11 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR RELEVANT NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL OF THE DEVICE HISTORY RECORD REVIEWED AS SUB-COMPONENTS ARE NOT LOT TRACKED. FURTHER REVIEW HAS SHOWN THAT THE NON-CONFORMITY WAS CREATED AS ONE PIECE OF THIS LOT DID GET DAMAGED ON THE TRANSPORTATION BETWEEN HAEGENDORF AND MONUMENT. THE DAMAGED PIECE HAS BEEN DISCARDED AND THE REMAINING 11 PIECES WERE RE-INSPECTED AND NO DAMAGE WAS DETECTED. THEREFORE IT IS UNLIKELY THAT THIS TRANSPORTATION DAMAGE IS RELEVANT FOR THE COMPLAINT CONDITION. HOWEVER, A FINAL CONCLUSION IS ONLY POSSIBLE AFTER A PHYSICAL EVALUATION OF THE DEVICE. 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.
IT WAS REPORTED THAT ON (B)(6) 2018, WHILE ASSEMBLING THE SET FOR THE FIRST TIME, THE RADIOLUCENT AIMING ARM WAS FOUND BROKEN IN THE ORIGINAL PACKAGE. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) RADIOLUCENT AIMING ARM. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 959685 | RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA | ROD,FIXATION,INTRAMEDULLARY | HSB | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 03.033.002 | L750748 | 10886982271068 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |