SHAFT FOR 90° SCREWDRIVER
Report
- Report Number
- 8030965-2022-00267
- Event Type
- Malfunction
- Date Received
- January 12, 2022
- Date of Event
- December 17, 2021
- Manufacturer
- SYNTHES GMBH
- Product Code
- HXX
- UDI-DI
- 07611819187474
- PMA / PMN Number
- K082649
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL DEVICE PRODUCT CODE: DZJ AND DZI. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. INITIAL REPORTER ADDRESS LINE 1: (B)(6). 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.
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, H4, H6: PART 03.505.003, LOT 8213958: MANUFACTURING SITE: SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: OCTOBER 07, 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PHOTO INVESTIGATION WAS COMPLETED: ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, DIFFERENT VIEWS OF A SHAFT FOR 90° SCREWDRIVER WERE SHOWN, HOWEVER, THE PHOTO DOES NOT PROVIDE SUFFICIENT INFORMATION RELATED TO THE REPORTED EVENT AND THEREFORE NO RESULT CAN BE OBTAINED FROM IT SINCE IT IS NOT POSSIBLE TO PERFORM A FUNCTIONAL TEST BASED ON THE PHOTOS PROVIDED. COMPLAINT RELEVANT DIMENSIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE ANALYSIS IS BASED ONLY ON THE PHOTOS PROVIDED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. 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 SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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. A PRODUCT INVESTIGATION WAS CONDUCTED. THE PRODUCT WAS RETURNED TO DEPUY SYNTHESE FOR EVALUATION. THE DEPUY SYNTHESE TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SHAFT HAD NO SURFACE DAMAGE/DEFECTS THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE DEVICE WAS RETURNED WITH ALL THE COMPONENTS STILL IN ASSEMBLED CONDITION; HOWEVER, THE COMPONENTS COULD NOT BE DISASSEMBLED, THIS CONDITION IS RELATED WITH THE CUSTOMER COMPLAINT. THE DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE COMPONENTS COULD NOT BE DISASSEMBLED. A FUNCTIONAL TEST TO ASSESS THE CONDITION OF THE INNER SHAFT WAS CONDUCTED. THE INNER SHAFT COULD NOT BE REMOVED FROM THE SCREWDRIVER SHAFT. THUS, DEVICE FAILED TO FUNCTION AS INTENDED. AS PART OF DEPUY SYNTHESE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE COMPLAINT CONDITION WAS CONFIRMED FOR THE SHAFT AS THE DEVICE COMPONENTS COULD NOT DISASSEMBLED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT CONDITION IS ATTRIBUTED TO A DESIGN- RELATED/MANUFACTURING ISSUE. FURTHER INVESTIGATION/ACTION REGARDING THIS DEVICE INTERACTION ISSUE IS BEING CONDUCTED UNDER NR. 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 REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, IT WAS DISCOVERED AT THE DISTRIBUTION CENTER THAT THE SHAFTS OF THE INSTRUMENTS WERE NOT ABLE TO BE DETACHED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SHAFT FOR 90° SCREWDRIVER. THIS IS REPORT 8 OF 12 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 781273 | SHAFT FOR 90° SCREWDRIVER | SCREWDRIVERS | HXX | SYNTHES GMBH | 8213958 | 07611819187474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |