25MM TAP
Report
- Report Number
- 1220246-2024-08856
- Event Type
- Malfunction
- Date Received
- December 16, 2024
- Date of Event
- November 18, 2024
- Report Date
- January 21, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 501
Narratives
ADDITIONAL INFORMATION. COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9621-25T / BATCH 022402 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE TIP HAD BROKEN. NO FRAGMENTS WERE RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE METHOD OF BONE PREPARATION AND THE QUALITY OF THE BONE ENCOUNTERED WERE NOT PROVIDED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A USER ERROR OF THE DEVICE DUE TO IMPROPER BONE PREPARATION, MISALIGNMENT INSERTION, AND/OR PRYING/LEVERAGING OF THE DEVICE DURING INSERTION.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION PROVIDED 12/26/2024: IT WAS FURTHER REPORTED THAT THE CASE WAS COMPLETED USING THE SAME INSTRUMENT FROM ANOTHER SET. THE BONE QUALITY OF THE PATIENT WAS REPORTED TO BE HARD BONE.
ON (B)(6)2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9621-25T 25MM TAP BROKE WHILE TAPPING AND AN AR-9401-17 ECLIPSE HUMERAL HEAD EXTRACTOR TIP BROKE OFF / DISTORTED WHILE REMOVING THE TRIAL. THIS WAS DISCOVERED DURING A REVERSE TOTAL SHOULDER PROCEDURE ON (B)(6) 2024 WITH NO PATIENT HARM. PIECE(S) BROKE OFF INSIDE OF THE PATIENT AND ALL BROKEN PIECES WERE RETRIEVED. THE CASE WAS COMPLETED SUCCESSFULLY AS NORMAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2393701 | 25MM TAP | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | 25MM TAP | 022402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |