EXPERT A2FN NAIL 9 R CANN L340 TAN LIGH
Report
- Report Number
- 8030965-2020-07305
- Event Type
- Injury
- Date Received
- September 22, 2020
- Report Date
- August 28, 2020
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- HSB
- UDI-DI
- 07611819323797
- Adverse Event
- 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, H6: PART NUMBER: 04.009.248S, LOT NUMBER: L896528, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 05. JUNE 2018, EXPIRY DATE: 01. JUNE 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 IS THE NAIL 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: 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: BASED ON THE PROVIDED INFORMATION HAD THE SURGEON DIFFICULTY IN REMOVING THE BROKEN NAIL. DUE TO THE CONDITION OF THE NAIL THIS DIFFICULTY CAN BE CONFIRMED. IT CAN BE ASSUMED THAT THE FRAGMENT WAS DIFFICULT TO REMOVE DUE TO THE CRACK AT THE SLOTTED LOCKING HOLE. THE SIDE WALL OF THE HOLE IS BENT OUTWARD AT THE CRACK AND DOES PROTRUDE FROM THE OUTER DIAMETER IN THIS AREA, IT IS POSSIBLE THAT THIS PROTRUDED MATERIAL DID ACT LIKE A BARBED HOOK AND CAUSED THE DIFFICULTY DURING THE REMOVAL. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE IDENTIFIED. THE LOT L896528 WAS MANUFACTURED IN JUNE 2018 WITH A LOT SIZE OF 18 PIECES 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.
DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (B)(4). 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 AN UNKNOWN DATE, THAT THE PATIENT¿S NAIL BROKE POST-OP. ON (B)(6) 2020, THE PATIENT UNDERWENT THE IMPLANT SURGERY WITH THE NAIL. ONE (1) MONTH AFTER THE SURGERY, THE PATIENT HAD 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 DID NOT FEEL ANY PAIN. AFTER THAT, THE PATIENT REPORTED PAIN, AND THE SURGEON CONFIRMED THAT THE NAIL HAD BEEN BROKEN AND MALUNION OCCURRED. ON (B)(6) 2020 THE PATIENT UNDERWENT THE REVISION SURGERY. IN THE REVISION WITH THE FULL ANESTHESIA, THE SURGEON HAD DIFFICULTY IN REMOVING THE BROKEN NAIL. THE SURGEON EXTENDED THE INCISION TO REMOVE IT, AND THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY IMPLANTING ANOTHER NAIL WITH A ONE (1) HOUR SURGICAL DELAY. THE SCHEDULED REVISION SURGERY TIME WAS FOUR (4) HOURS. 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. CONCOMITANT DEVICE REPORTED: HIP SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), LOCKING SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), END CAP FOR A2FN (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) WAS CREATED TO CAPTURE THE INTRA-OPERATIVE EVENT OF THE DEVICE REMOVAL AND THE SURGEON HAVING DIFFICULTY IN REMOVING THE BROKEN NAIL. (B)(4) CAPTURED POST-OPERATIVE EVENT. THIS REPORT INVOLVES ONE (1) EXPERT A2FN NAIL Ø9 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 |
|---|---|---|---|---|---|---|---|
| 1031544 | 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| UNK - NAIL HEAD ELEMENTS: HIP SCREW| UNK - SCREWS: LOCKING |