ELBOW TORQUE DRIVER
Received Jul 30, 2026 · Event occurred Jul 7, 2026
Report 0001822565-2026-02717 · MDR key 50090260
Device
Generic name
Prosthesis, Elbow, Constrained, Cemented
Manufacturer
Zimmer Biomet, Inc.Catalog number
00840108000
Lot number
56708041
Product problems
- Fracture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that during an elbow arthroplasty, the tip of a torque driver broke while inserting a humeral screw. The broken tip became lodged in the screw head; the screw was removed using pliers, a replacement screw was inserted, and the procedure was completed without issues or delay. There were no consequences or impact to the patient. No further information has been provided.
Additional Manufacturer Narrative
(b)(4)G2: Foreign - Event occurred in Japan.The product has been received by Zimmer Biomet and the investigation is in process. Once the investigation has been completed, a follow-up MDR will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer Biomet will continue to monitor for trends.