DRIVER, T10 HEXALOBE
Received Dec 16, 2025 · Event occurred Nov 25, 2025
Report 1220246-2025-05629 · MDR key 23817023
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
DRIVER, T10 HEXALOBECatalog number
AR-8944DH
Lot number
130964
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 11/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8944DH DRIVER TIP WAS TWISTED. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM. ADDITIONAL INFORMATION PROVIDED ON 12/2/2025: IT WAS FURTHER REPORTED THAT THIS OCCURRED DURING A CLAVICLE FRACTURE PROCEDURE, AND THE CASE WAS COMPLETED WITH ANOTHER DRIVER. NO PATIENT HARM OR CASE DELAY WAS REPORTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6 ONE UNPACKAGED AR-8944DH BATCH 130964 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE DRIVER TIP WAS TWISTED AND BENT. FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE OF THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS USER ERROR WITH THE DEVICE, RESULTING FROM OVER-TORQUING/OVER-ENGAGING THE INSERTER WITHIN THE SCREW DURING USE. THE COMPLAINT ALLEGATION WAS CONFIRMED. REFER TO THE INVESTIGATION PHOTOS.