ANGLED REAMER, DRIVE SHAFT
Report
- Report Number
- 1220246-2024-08546
- Event Type
- Malfunction
- Date Received
- November 15, 2024
- Date of Event
- November 7, 2024
- Report Date
- January 28, 2025
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867324954
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: D9, G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-9676 SERIAL/BATCH NUMBER 022339 WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING WITH THE RETURNED MATTING PART AR-9597-10, BATCH 1037622109 FOUND RESISTANCE AND FRICTION. THE VISUAL EVALUATION REVEALED HEAVY SCRATCHES AND LINES AT THE DISTAL AND PROXIMAL END CONSISTENT WITH SIGNS OF FRICTION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: B5, G3, H6.
ON 11/07/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4). THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT COLD WELDED TO THE SLEEVE AND BECAME STUCK. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.
THE CASE WAS COMPLETED BY DISASSEMBLING THE DEVICES AND REASSEMBLING THEM. 5 MINUTE DELAY TO CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1306727 | ANGLED REAMER, DRIVE SHAFT | MANUAL INSTR, GENERAL SURGICAL | LXH | ARTHREX, INC. | ANGLED REAMER, DRIVE SHAFT | 022339 | 00888867324954 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |