ATTUNE TIBIAL DRILL TOWER
Report
- Report Number
- 1818910-2026-00704
- Event Type
- Malfunction
- Date Received
- January 13, 2026
- Date of Event
- December 20, 2025
- Manufacturer
- DEPUY IRELAND - 9616671
- Product Code
- HWT
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING FOR INFORMATION RECEIVED, THE TIBIA DRILL (254500165) IS NOT SMOOTH AS IT SUPPOSE TO BE WHEN GOING THROUGH THE TIBIA TOWER (254500131) IN SET # (B)(4). THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES, HOWEVER PHOTOS WERE PROVIDED FOR REVIEW. SEE ATTACHMENT GHK M21 VIDEO.MP4. THE VIDEO INVESTIGATION REVEALED THAT IS NOT POSSIBLE TO ASSEMBLE THE ATTUNE LTL CEM TIBIAL DRILL WITH THE ATTUNE TIBIAL DRILL TOWER, AND IT IS NECESSARY TO MANEUVER IT IN DIFFERENT WAYS IN ORDER TO ACHIEVE PROPER ASSEMBLY. THE OBSERVED CONDITION OF THE DEVICE COULD BE CONSISTENT WITH EXPOSURE TO UNINTENDED FORCES, SUCH AS HEAVY USAGE, OFF AXIS ASSEMBLY, WHICH MAY HAVE LED TO INTERNAL DAMAGE. HOWEVER, SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE CONNECTION SECTION WAS NOT CLEARLY VISIBLE, IT WAS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED CONDITION. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. AS THE DEVICE WAS NOT RETURNED, AND AS-RECEIVED CONDITION COULD NOT BE ASSESSED, A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE TIBIAL DRILL TOWER WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING FOR INFORMATION RECEIVED, THE TIBIA DRILL (254500165) IS NOT SMOOTH AS IT SUPPOSE TO BE WHEN GOING THROUGH THE TIBIA TOWER (254500131) IN SET #ZNHKJTATTUNEM21. THE PRODUCT WAS NOT RETURNED TO DEPUY SYNTHES; HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE VIDEO INVESTIGATION REVEALED THAT IS NOT POSSIBLE TO ASSEMBLE THE ATTUNE LTL CEM TIBIAL DRILL WITH THE ATTUNE TIBIAL DRILL TOWER, AND IT IS NECESSARY TO MANEUVER IT IN DIFFERENT WAYS IN ORDER TO ACHIEVE PROPER ASSEMBLY. THE OBSERVED CONDITION OF THE DEVICE COULD BE CONSISTENT WITH EXPOSURE TO UNINTENDED FORCES, SUCH AS HEAVY USAGE, OFF AXIS ASSEMBLY, WHICH MAY HAVE LED TO INTERNAL DAMAGE. HOWEVER, SINCE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND THE CONNECTION SECTION WAS NOT CLEARLY VISIBLE, IT WAS DIFFICULT TO DETERMINE THE EXACT CAUSE OF THE REPORTED CONDITION. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. AS THE DEVICE WAS NOT RETURNED, AND AS-RECEIVED CONDITION COULD NOT BE ASSESSED, A DIMENSIONAL INSPECTION AND DOCUMENT/SPECIFICATION REVIEW WERE NOT COMPLETED. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE TIBIAL DRILL TOWER WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: ACCORDING FOR INFORMATION RECEIVED, THE TIBIA DRILL (254500165) IS NOT SMOOTH AS IT SUPPOSE TO BE WHEN GOING THROUGH THE TIBIA TOWER (254500131) IN SET #ZNHKJTATTUNEM21. THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. THE DEPUY SYNTHES TEAM CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE ATTUNE TIBIAL DRILL TOWER WAS DEFORMED AT THE INNER SECTION AND THE TOP EDGE. ADDITIONALLY, SOME SCRATCHES WERE OBSERVED AT THE ENTIRE SURFACE. THE OVERALL OBSERVED CONDITION WAS IDENTIFIED AS AN END OF LIFE INDICATOR; DAMAGE CONSISTENT WITH REPEATED USE AND SERVICING. THE LIFECYCLE REQUIREMENTS OF THE DEVICE ARE EVENT RELATED AND DEPEND ON THE USE AND INSPECTION OF THE DEVICE IN CLINICAL PRACTICE. AS THE DEVICE CAN BE DAMAGED ON THE FIRST OR 100TH USE, THE DEVICE MUST BE PROPERLY INSPECTED PRIOR TO EACH SURGICAL USE. REFER TO THE DEVICE/COUNTRY SPECIFIC IFU FOR INFORMATION RELATED TO END OF LIFE, REPROCESSING INSTRUCTIONS, AND INSPECTION PROCEDURES. A DIMENSIONAL INSPECTION WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. A FUNCTIONAL TEST REVEALED THAT IT IS NOT POSSIBLE TO ASSEMBLE THE ATTUNE LTL CEM TIBIAL DRILL WITH THE ATTUNE TIBIAL DRILL TOWER, AND IT IS NECESSARY TO MANEUVER IT IN DIFFERENT WAYS IN ORDER TO ACHIEVE PROPER ASSEMBLY. THE REPORTED ALLEGATION CAN BE CONFIRMED AS THE OBSERVED FAILURE MODE PREVENTS THE DEVICE WORKING AS INTENDED IN THE SAME MANNER. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE ATTUNE TIBIAL DRILL TOWER WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, THE POTENTIAL CAUSE IS TRACED TO END OF LIFE, AND IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. CORRECTED: H3.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: ADDED: D9. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL MANUFACTURER NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIBIA DRILL WAS NOT SMOOTH AS IT WAS SUPPOSED TO BE WHEN GOING THROUGH THE TIBIA TOWER. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96583 | ATTUNE TIBIAL DRILL TOWER | DRILL GUIDES | HWT | DEPUY IRELAND - 9616671 | SO2017734 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |