REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
Report
- Report Number
- 2939274-2019-61887
- Event Type
- Malfunction
- Date Received
- October 31, 2019
- Date of Event
- October 15, 2019
- Report Date
- October 15, 2019
- Manufacturer
- WRIGHTS LANE SYNTHES USA PRODUCTS LLC
- Product Code
- HTD
- UDI-DI
- 10886982203175
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- 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. PART NUMBER: 399.99. LOT NUMBER: A7DA001. MANUFACTURING SITE: TUTTLINGEN. RELEASE TO WAREHOUSE DATE: WEEK 01, 1994. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE, THE DHR IS NO LONGER AVAILABLE DUE TO THE AGE OF THE INSTRUMENT (OVER 25 YEARS OLD). HOWEVER, A MANUFACTURING-RELATED POTENTIAL CAUSE WAS NOT SUSPECTED, THEREFORE, PER FRANCHISE COMPLAINT PRODUCT INVESTIGATION PROCEDURE, NO MANUFACTURING RECORD EVALUATION IS REQUIRED. THE REDUCTION FORCEPS WITH SERRATED JAW- RATCHET 144 MM (P/N:399.99, LOT # A7DA001) WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE JAWS OF THE DEVICE WERE BROKEN AND THE BROKEN FRAGMENTS WERE RECEIVED AT US CQ. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DEVICE FAILURE/DEFECT IDENTIFIED? YES. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION CAN BE PERFORMED DUE TO POST-MANUFACTURING DAMAGE. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DESIGN OF THE DEVICE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE THE RESPECTIVE DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION WERE REVIEWED COMPLAINT CONFIRMED? YES, THE DEVICE RECEIVED IS BROKEN. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE REDUCTION FORCEPS WITH SERRATED JAW- RATCHET 144 MM (P/N:399.99, LOT # A7DA001) . THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. 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.
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. CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGE(S) PROVIDED IN THE ATTACHMENT(S) ¿(B)(4) PRODUCT PICTURE." THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION COULD NOT BE CONFIRMED AS RECEIVED PICTURES SHOWS THAT THE THE JAWS OF THE DEVICE IS BROKEN INTO TWO PIECES. SINCE THE DEVICE WAS NOT RETURNED, DIMENSIONAL, MATERIAL AND DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE PROVIDED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) 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. 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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. UPDATED LOT NUMBER TO A7DA001 INVESTIGATION SUMMARY CUSTOMER QUALITY INVESTIGATION: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR INVESTIGATION. THE FOLLOWING INVESTIGATION IS BASED ON THE IMAGE(S) PROVIDED IN THE ATTACHMENT(S) ¿(B)(4) PRODUCT PICTURE." THE IMAGE(S) WAS REVIEWED, AND THE COMPLAINT CONDITION COULD BE CONFIRMED AS RECEIVED PICTURES SHOWS THAT THE JAWS OF THE DEVICE IS BROKEN INTO TWO PIECES. SINCE THE DEVICE WAS NOT RETURNED, DIMENSIONAL, MATERIAL AND DRAWING REVIEWS ARE NOT APPLICABLE. A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED AS THE LOT NUMBER COULD NOT BE DETERMINED FROM THE IMAGE PROVIDED. A DEFINITIVE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED (BASED ON THE IMAGES) 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. 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.
PRODUCT COMPLAINT #: (B)(4). 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.
IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FIBULA PROCEDURE ON (B)(6) 2019, THE REDUCTION FORCEPS WITH SERRATED JAW-RATCHET WAS BROKEN INTO TWO PIECES WHILE THE SURGEON WAS TRYING TO ROTATE THE DISTAL TIBIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF ANOTHER CRAB CLAWS FORCEPS. THE BROKEN FRAGMENTS WERE EASILY REMOVED. PATIENT STATUS WAS FINE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1057528 | REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM | FORCEPS | HTD | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | 399.99 | A7DA001 | 10886982203175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |