JGRKNT 1.0MM MINI 2-0 NDL 10PK
Received Jul 20, 2026 · Event occurred Jun 24, 2026
Report 0001825034-2026-02136 · MDR key 25873879
Device
Generic name
Screw, Fixation, Intraosseous
Manufacturer
Zimmer Biomet, Inc.Catalog number
912080
Lot number
0002640192
Product problems
- Fracture
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING SUTURING, THE SUTURE AND NEEDLE BROKE INTRA-OPERATIVELY, AND SUTURING COULD NOT BE COMPLETED WITH THE ORIGINAL ANCHOR. AN ADDITIONAL ANCHOR WAS INSERTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE ORIGINAL ANCHOR WAS EVALUATED AND LEFT IN PLACE. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - EVENT OCCURRED IN CHINA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.