T10 HEXALOBE, CMP FT
Report
- Report Number
- 1220246-2025-04199
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- September 12, 2025
- Report Date
- January 28, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION: B5, G3, H6.
ADDITIONAL INFORMATION: G3, H3, H6 THE COMPLAINT ALLEGATION IS CONFIRMED BY PHOTOGRAPHIC EVIDENCE SHOWING A BROKEN TIP ON AN AR-8737-38, BATCH, UNK. BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICES (IF AVAILABLE), PHOTOGRAPHS, THE EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE IS MOST LIKELY ATTRIBUTED TO USE-RELATED FACTORS, SPECIFICALLY EXCESSIVE TORQUE OR FORCE APPLIED DURING SCREW REMOVAL, WHICH CAN EXCEED THE MECHANICAL LIMITS OF THE DRIVER TIP DURING HARDWARE EXPLANTATION.
ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THREE DRIVER SHAFTS BROKE DURING A CASE. THE PARTS INCLUDED IN THE REPORT WERE AR-8741-40S 3.5 MM CANNULATED FIBERTAK BEVELED DRIVER AND AR-8737-38 CANNULATED T10 HEX DRIVER SHAFT. THE ISSUE OCCURRED WHEN THE SURGEON ATTEMPTED TO REMOVE THE SCREWS, AND THE TIP OF THE DRIVER SNAPPED OFF. THE BROKEN PIECES WERE SUCCESSFULLY EXTRACTED, AND NO ADVERSE EFFECTS WERE REPORTED FOR THE PATIENT. THIS WAS DISCOVERED DURING A HARDWARE REMOVAL PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON THE THIRD DRIVER'S INFORMATION AND CASE DETAILS ON 09/17/2025.
ADDITIONAL INFORMATION WAS RECEIVED ON 09/29/2025: HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2025 AT THE PATIENT¿S REQUEST, WITH NO SYMPTOMS REPORTED. TWO AR-8740-XXH 4.0 MM COMPRESSION FT SCREWS FROM A PRIOR MIS BUNIONECTOMY WERE REMOVED. NO OTHER ARTHREX IMPLANTS WERE PLACED DURING THE PROCEDURE. TWO AR-8741-40S 3.5 MM CANNULATED FIBERTAK BEVELED DRIVERS SNAPPED, ALONG WITH ONE AR-8737-38 CANNULATED T10 HEX DRIVER SHAFT. THE CASE WAS DELAYED BY 30 MINUTES, BUT ALL HARDWARE WAS SUCCESSFULLY EXPLANTED. NO OTHER SCREWS WERE INVOLVED, AND IT¿S UNCLEAR IF ADDITIONAL ANESTHESIA WAS USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317044 | T10 HEXALOBE, CMP FT | ORTHOPEDIC MANUAL SURG INSTR | LXH | ARTHREX, INC. | T10 HEXALOBE, CMP FT | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |