3.2MM GUIDE WIRE 400MM
Report
- Report Number
- 2939274-2020-02215
- Event Type
- Injury
- Date Received
- May 4, 2020
- Date of Event
- April 17, 2020
- Report Date
- April 17, 2020
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- LXH
- UDI-DI
- 07611819738393
- PMA / PMN Number
- EXEMPT
- 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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: A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: THE INVESTIGATION OF THE DRILL TIP GUIDE WIRE HAS SHOWN THAT AT THE THREADED TIP SOME FLATTENED THREAD FLANKS ARE VISIBLE. FURTHER INVESTIGATION HAS SHOWN THAT THERE ARE DENTS / MARKS VISIBLE AT THE WIRE SURFACE AS WELL AS THE WIRE IS BENT. DIMENSIONAL INSPECTION: THE MEASURED DIMENSION WAS FOUND TO BE WITHIN THE GIVEN SPECIFICATIONS PER THE DRAWINGS REFERENCED ABOVE. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING, DIMENSIONS, MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. SUMMARY: THE COMPLAINT IS RATED AS CONFIRMED FOR THIS DRILL TIP GUIDE WIRE AS THE WIRE IS DAMAGED AND BENT. BASED ON THE INFORMATION WE RECEIVED WE CAN ONLY ASSUME THAT THE MENTIONED NARRATIVE "AS THE GUIDE WIRE WAS INSERTED WITH AN EXCESSIVE FORCE, THE TIP OF THE GUIDE WIRE SLIPPED OFF THE CORTICAL BONE AND WAS POSITIONED OUTSIDE THE HOLE OF THE NAIL" DID LEAD TO THE COMPLAINED MALFUNCTION AND FINALLY THE DEFORMATION / DAMAGE OF THE DRILL TIP GUIDE WIRE. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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, H4, H6: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART NUMBER: 357.399, LOT NUMBER: 17L0185, PART MANUFACTURING DATE: 23 SEPTEMBER 2019, MANUFACTURING SITE: ELMIRA, PART EXPIRATION DATE: N/A, NONCONFORMANCE NOTED: N/A. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 17L0185 OF 3.2 MM GUIDE WIRES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE COMPONENT DEVICE HISTORY RECORD(S) DETERMINED THE COMPONENT LOT 12L8368 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOT H855074 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.
CONCOMITANT DEVICES REPORTED: LOCKING SCREW FOR NAILS TAN LIGHT GREEN (PART#04.005.522S, LOT#28P3388, QUANTITY 1).
CONCOMITANT DEVICES REPORTED: TFNA HELICAL BLADE (PART # 04.038.295S, LOT # 24P0855, QUANTITY 1);TFNA NAIL (PART # 04.037.914S, LOT # H812878, QUANTITY 1); SLEEVE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); LOCKING SCREW FOR NAILS TAN LIGHT GREEN (PART#04.005.522S, LOT#28P3388, QUANTITY 1).
THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 SURGERY FOR TROCHANTERIC FRACTURES (RIGHT) BY USING THE TFNA SYSTEM. DURING THE PROCEDURE, THE SURGEON HAD DIFFICULTY IN FRACTURE REDUCTION. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY. THIRTY (30) MINUTES AFTER THE SURGERY, THE CT SCAN CONFIRMED THAT THE BLADE HAD BEEN FIXED OFF THE NAIL. THE PROTECTION SLEEVE FOR GUIDE WIRE WAS NOT PROPERLY APPLIED ONTO THE CORTICAL BONE THUS A GAP HAPPENED BETWEEN THE PROTECTION SLEEVE AND THE CORTICAL BONE. AS THE GUIDE WIRE WAS INSERTED WITH AN EXCESSIVE FORCE, THE TIP OF THE GUIDE WIRE SLIPPED OFF THE CORTICAL BONE AND WAS POSITIONED OUTSIDE THE HOLE OF THE NAIL. THE BLADE WAS INSERTED OVER THE GUIDE WIRE THAT WAS NOT PROPERLY POSITIONED, RESULTING IN THE DISLOCATION OF THE BLADE. ON (B)(6) 2020, CORRECTIVE SURGERY WAS PERFORMED TO REMOVE ALL THE TFNA IMPLANTS AND THEN IMPLANT OTHER TFNA IMPLANTS OF THE SAME SIZE. THE SURGERY WAS SUCCESSFULLY COMPLETED. TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) FEMORAL NAIL (PART # 04.037.914S, LOT # UNKNOWN, QUANTITY 1), LOCKING SCREW FOR NAILS TAN LIGHT GREEN (PART # 04.005.522S, LOT # 28P3388, QUANTITY 1). THIS IS REPORT 3 OF 4 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485456 | 3.2MM GUIDE WIRE 400MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 07611819738393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN| LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN| LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN| TFNA FEM NAIL Ø9 R 125° L235 TIMO15| TFNA FEM NAIL Ø9 R 125° L235 TIMO15| TFNA HELICAL BLADE L95 TAN| TFNA HELICAL BLADE L95 TAN| UNK - GUIDE/COMPRESSION/K-WIRES| UNK - GUIDE/COMPRESSION/K-WIRES |