UNKNOWN SCREW
Received Jul 17, 2026 · Event occurred Jul 2, 2026
Report 3025141-2026-00367 · MDR key 25855977
Device
Generic name
Screw, Fixation, Bone
Manufacturer
Acumed, LlcModel number
UNKNOWN SCREWLot number
NOT REPORTED
Product problems
- Break
Patient
Not reported
- Nonunion/Delayed-union Bone Fracture
Narrative
Description of Event or Problem
IT WAS REPORTED BY AN ACUMED SALES REPRESENTATIVE THAT THE SURGEON WENT IN FOR A HARDWARE REMOVAL OF AN ACULOC 2 DISTAL RADIUS. THE ULNAR SIDED DISTAL SCREW HAD BROKEN. THE INCIDENT WAS NOT ORIGINALLY REPORTED BECAUSE THE PATIENT WAS AN AMPUTEE USING A WHEELCHAIR. THAT PATIENT WAS PLACING FULL BODY WEIGHT THROUGH HIS FRACTURE ONTO THE CHAIR AND BROKE SCREWS 1 WEEK POST-OP. THE SURGEON WAS NOT OVERLY SURPRISED OR SIGNIFICANTLY FRUSTRATED. THE PATIENT THIS COMPLAINT REPORT IS DEDICATED TO WAS AS TOLD BY THE SURGEON NOT DOING ANYTHING OUT OF THE ORDINARY.
Additional Manufacturer Narrative
TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION AND HAS BEEN REPORTED TO ACUMED THAT IT WILL NOT BE RETURNED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.