ANGLED ACET INSERTR
Report
- Report Number
- 1818910-2022-02602
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Date of Event
- January 31, 2022
- Report Date
- February 9, 2022
- Manufacturer
- DEPUY INTERNATIONAL LTD - 8010379
- Product Code
- HWR
- UDI-DI
- 10603295221890
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(4). INFORMATION WAS RECEIVED INDICATING THAT "HANDLE IS CRACKED." DUE TO THIS, DEPUY SYNTHES JOINT RECONSTRUCTION CONSIDERS THE DEVICE ON THIS REPORT TO BE NOT REPORTABLE. FURTHER UPDATES WILL ONLY BE PROVIDED IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE REGULATORY DETERMINATION. INVESTIGATION SUMMARY EXAMINATION OF THE RETURNED DEVICE CAN CONFIRM THE COMPLAINT. DURING THE ANALYSIS THE DEVICE IS FOUND CRACKED. THE SHAFT ASSEMBLY AND THE ROTATING LOCKING CATCH WERE NOT SENT BACK FOR ANALYSIS. THE COMPLAINT IS CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. THE INFORMATION RECEIVED STATES: ¿IT WAS REPORTED THAT THE HANDLE OF THE PRIMARY MAC INSERTER WAS CRACKED.¿ THE PHYSICAL DEVICE WAS RETURNED FOR INVESTIGATION. DURING ANALYSIS, THE ANGLED ACET INSERTR WAS FOUND CRACKED FROM THE FRAME HANDLE. THE SHAFT ASSEMBLY AND THE ROTATING LOCKING CATCH WERE NOT SENT BACK FOR ANALYSIS. THE COMPLAINT IS CONFIRMED. MANUFACTURING DATE: MARCH, 2018. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL PREVIOUS REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION. 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). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED. THE DEVICE IS FOUND WITH WEAR MARKS. POTENTIAL CAUSE CAN BE ATTRIBUTED TO A NORMAL WEAR. THERE IS NO INFORMATION AVAILABLE THAT INDICATES THE CAUSE OF THE MISSING PARTS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. 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). WHERE THE PRODUCT AND LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
INSERTION HANDLE IS BROKEN.
THE HANDLE OF THE PRIMARY MAC INSERTER WAS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71138 | ANGLED ACET INSERTR | HIP INSTRUMENTS : INSERTION DEVICES | HWR | DEPUY INTERNATIONAL LTD - 8010379 | 9200-10-029 | MJ3601701 | 10603295221890 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |