ANGLED REAMER, DRIVE SHAFT
Report
- Report Number
- 1220246-2024-07536
- Event Type
- Malfunction
- Date Received
- September 11, 2024
- Date of Event
- August 15, 2024
- Report Date
- October 1, 2024
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867324954
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED, AR-9676, BATCH 022304, WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION NOTED SIGNS OF WEAR ON THE DEVICE: CIRCUMFERENTIAL GRINDING ON THE DISTAL AND PROXIMAL TIP. FUNCTIONAL TESTING WAS PERFORMED WITH A KNOWN GOOD AND IT WAS FOUND THAT THE REAMER CANNOT BE MOVED FREELY WITHIN THE MATING PART. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO INTERFERENCE WITH THE MATING INSTRUMENT.
ON (B)(6) 2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-06637671 THAT AN AR-9676 ANGLED REAMER DRIVE SHAFT WAS SLOWLY WELDED TOGETHER WITH THE AR-9597-10 ANGLED REAMER SLEEVE BEFORE REAMING THE GLENOID. THE INSTRUMENTS WERE PUT ASIDE, AND A BACKUP TRAY WAS OPENED TO COMPLETE THE CASE WITH NO ISSUES. THIS WAS DISCOVERED DURING AN RTSA PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 08/19/2024: NO CASE DELAY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1584867 | ANGLED REAMER, DRIVE SHAFT | MANUAL INSTR, GENERAL SURGICAL | LXH | ARTHREX, INC. | ANGLED REAMER, DRIVE SHAFT | 022304 | 00888867324954 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |