MalfunctionLXH
OFFSET FLEX CLAMPING
Received Jul 31, 2026 · Event occurred Jul 7, 2026
Report 0001825034-2026-02252 · MDR key 50105714
Device
Generic name
Orthopedic Manual Surgical Instrument
Manufacturer
Zimmer Biomet, Inc.Catalog number
31-555408
Lot number
UNK
Product problems
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that the broach handle is broken. There was no known impact or consequences to the patient. Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4). The customer has indicated that the product is in process of being returned to Zimmer Biomet for investigation. Once the investigation has been completed, a Follow-up MDR will be submitted.