UNK INSERTION DEVICE
Report
- Report Number
- 1818910-2024-12784
- Event Type
- Malfunction
- Date Received
- June 12, 2024
- Date of Event
- May 30, 2024
- Report Date
- June 12, 2024
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY SRI INSTRUMENT: PRODUCT CODE: APAU0213, DESCRIPTION: MODULAR CORAIL STEM INSERTER, LOT NUMBER: ENZ190916 NO INSTRUMENT IS RETURNING TO FRANCHISE FOR INVESTIGATION. THE PRODUCT WILL BE INVESTIGATED LOCALLY BY THE SRI TEAM AUSTRALIA. A REPORT WILL BE PROVIDED TO FRANCHISE UPON COMPLETION OF THE INVESTIGATION. DETAILS: RIGHT TOTAL HIP REPLACEMENT ANTERIOR: THE NIPPLE ON THE MODULAR CORAIL STEM INSERTER BROKE (PICTURES ATTACHED) ON IMPACTING THE FEMORAL IMPLANT. THE SURGEON WAS NOT ABLE TO LOCATE THE BROKEN PIECE IN THE WOUND. USED KINCISE IMPACTOR BULLET TO SEAT IMPLANT. APPROX 2 MINS WERE TAKEN IN ORDER TO FIND THE BROKEN NIPPLE IN THE WOUND. THIS INSTRUMENT IS FROM ONE OF THE CONSIGNMENT TRAYS AT KNOX. BROKEN INSTRUMENT IS AVAILABLE TO BE RETURNED. THE PRODUCT WAS RETURNED TO J&J MEDTECH ORTHOPAEDICS SRI TEAM AND THE ISSUE COULD BE CONFIRMED. ADDITIONALLY, PHOTOS WERE PROVIDED FOR REVIEW, SEE ATTACHMENTS PC 001621371 IMG_1820, (B)(4) POST OP XRAY, PC-001621371 MAIN SOURCE, (B)(4) IMG_1819, (B)(4) IMAGE. VISUAL INSPECTION OF THE MODULAR CORAIL STEM INSERTER (APAU0213) REVEALED WEAR AND TEAR AT THE TIP FROM NORMAL USE (WITH IMPACTION). BROKEN FRAGMENT WAS NOT RETURNED FOR EVALUATION. THE OBSERVED CONDITIONS WERE 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 WAS NOT PERFORMED SINCE IT WAS NOT APPLICABLE TO THE COMPLAINT CONDITION. THE OVERALL COMPLAINT WAS CONFIRMED AS THE OBSERVED CONDITION OF THE MODULAR CORAIL STEM INSERTER (APAU0213) WOULD HAVE CONTRIBUTED TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, 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 J&J MEDTECH ORTHOPAEDICS 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 RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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. 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. THIS REPORT MAY BE BASED ON INFORMATION THAT 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. 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. 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. H10 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.
DETAILS: RIGHT TOTAL HIP REPLACEMENT ANTERIOR : THE NIPPLE ON THE MODULAR CORAIL STEM INSERTER BROKE ON IMPACTING THE FEMORAL IMPLANT. THE SURGEON WAS NOT ABLE TO LOCATE THE BROKEN PIECE IN THE WOUND. USED KINCISE IMPACTOR BULLET TO SEAT IMPLANT. APPROX 2 MINS WERE TAKEN IN ORDER TO FIND THE BROKEN NIPPLE IN THE WOUND.
ADDITIONAL INFORMATION WAS RECEIVED: CLOSURE SUMMARY: THE TIP OF THE INSTRUMENT BROKE ON IMPACT. A SEARCH BY THE SURGEON DID NOT REVEAL THE MISSING IMPACTOR TIP. DUE TO THE MISSING PIECE, PATIENT HARM IS ASSUMED. THIS COMPLAINT HAS BEEN REPORTED TO THE TGA AS AN ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153169 | UNK INSERTION DEVICE | INSERTION DEVICE | HWE | DEPUY ORTHOPAEDICS INC US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male |