EXPERT A2FN NAIL 9 R CANN L340 TAN LIGH
Report
- Report Number
- 8030965-2020-07330
- Event Type
- Injury
- Date Received
- September 22, 2020
- Date of Event
- January 1, 2020
- Report Date
- August 28, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819323797
- Adverse Event
- Yes
- 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. G5: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. H3, H6: PART: 04.009.248S, LOT: L896528, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: JUNE 05, 2018, EXPIRY DATE: MAY 01, 2028. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE RECEIVED NAIL IS BROKEN APART AT THE UPPER DISTAL LOCKING HOLE. THE FRAGMENT WAS RETURNED FOR EVALUATION, THE INSPECTION OF THE FRAGMENT HAS SHOWN THAT THERE IS ALSO A CRACK AT ONE SIDE OF THE SLOTTED DISTAL LOCKING HOLE. THE SIDE WALL OF THE HOLE IS BENT OUTWARD AT THE CRACK. OTHERWISE, THE NAIL IS IN A GOOD CONDITION WITH SOME SLIGHT DISCOLORATIONS AND SCRATCHES, CONCORDANT WITH DEVICE THAT WAS INSERTED/REMOVED AND IN SITU FOR A CERTAIN TIME. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER PER DRAWING: OUTER SHAFT DIAMETER PASS OUTER SHAFT DIAMETER AT SLOTS PASS HOLE DIAMETER PASS WIDTH SLOTTED HOLE DAMAGED, SLOT WIDENED UP DUE TO CRACK HEIGHT SLOTTED HOLE PASS. DOCUMENT/SPECIFICATION REVIEW: DRAWING WAS REVIEWED TO VERIFY THE RELEVANT DIMENSIONS AND THE MATERIAL SPECIFICATION. THE CURRENT DRAWING REVISION IS IN PLACE SINCE APRIL 2008, WHICH SPEAKS AGAINST A DESIGN RELATED ISSUE. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THE USED MATERIAL OF THE LOT IN QUESTION WAS ACCORDING TO ISO NORM 5832-11 FOR WROUGHT TITANIUM 6-ALUMINIUM 7-NIOBIUM ALLOY IMPLANTS FOR SURGERY AS REQUIRED PER DRAWING. INVESTIGATION CONCLUSION: THE COMPLAINT IS RATED AS CONFIRMED AS THE NAIL IS BROKEN AS COMPLAINED. DURING THE PERFORMED EVALUATION, NO MANUFACTURING RELATED ISSUE COULD BE IDENTIFIED. THE LOT L896528 WAS MANUFACTURED IN JUNE 2018 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. BASED ON THE PROVIDED INFORMATION, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE BREAKAGE AND THE CRACK. WE CAN ONLY ASSUME THAT ANY OCCURRENCE DURING THE HEALING PROCESS, LIKE THE IN THE DESCRIPTION MENTIONED MAL-UNION OR OTHER FACTORS LIKE NON-UNION, DELAYED UNION, OVERLOADING OF THE OSTEOSYNTHESIS, OR FINALLY A COMBINATION OF DIFFERENT FACTORS, DID LEAD TO A FATIGUE FAILURE OF THE NAIL. 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 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.
EVENT OCCURRED ON AN UNKNOWN DATE IN 2020. (B)(4). 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.
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE IMPLANT SURGERY WITH THE NAIL IN QUESTION. ONE (1) MONTH AFTER THE SURGERY, THE PATIENT WAS NON-WEIGHT BEARING AND TWO (2) WEEKS AFTER, SHE HAD PARTIAL WEIGHT BEARING AND WAS FOLLOWED UP. WHEN THE PATIENT REHABILITATED, THERE WAS METALLIC SOUND. THE SURGEON THOUGHT THAT IT WAS POSSIBLE THAT A SCREW WAS BROKEN, BUT THE X-RAYS WERE NOT TAKEN BECAUSE THE PATIENT WAS NOT EXPERIENCING ANY PAIN. AFTER THAT, THE PATIENT REPORTED PAIN, AND THE SURGEON CONFIRMED THAT THE NAIL HAD BEEN BROKEN AND MALUNION OCCURRED. ON AUGUST 28, 2020, THE PATIENT UNDERWENT THE REVISION SURGERY. IN THE REVISION, THE SURGEON HAD DIFFICULTY IN REMOVING THE BROKEN NAIL. THE SURGEON EXTENDED THE INCISION TO REMOVE IT, AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY BY IMPLANTING ANOTHER NAIL WITH ONE (1) HOUR SURGICAL DELAY. THE SURGEON COMMENTED THAT THE FIXATION STRENGTH MIGHT BE WEAK BECAUSE THE NAIL WAS THIN. THE PATIENT MIGHT BE OVERLOADING AT HER DAILY LIFE DURING NON-WEIGHT AND PARTIAL BEARING. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN HIP SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN, UNKNOWN END CAP FOR A2FN (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR ONE (1) EXPERT A2FN NAIL 9 R CANN L340 TAN LIGH. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032622 | EXPERT A2FN NAIL 9 R CANN L340 TAN LIGH | ROD, FIXATION, INTRAMEDULLARY | HSB | OBERDORF SYNTHES PRODUKTIONS GMBH | L896528 | 07611819323797 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention | UNK - END CAPS: A2FN| UNK - END CAPS: A2FN| UNK - NAIL HEAD ELEMENTS: HIP SCREW| UNK - NAIL HEAD ELEMENTS: HIP SCREW| UNK - SCREWS: LOCKING: TRAUMA| UNK - SCREWS: LOCKING: TRAUMA |