inforMED
MalfunctionGFG

2.0MM DRILL BIT W/DEPTH MARK QC/110MM

Received Jul 27, 2026 · Event occurred Jul 4, 2026

Report 8030965-2026-07754 · MDR key 50046990

Device

Generic name

Bit, Surgical

Manufacturer

Synthes Gmbh

Catalog number

310.534

Lot number

5155P04

Product problems

  • Break

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

It was reported that during the procedure, as the specialist was preparing to use the drill bit, the tip snapped off upon contact with the cortical bone; it did not remain inside the patient, nor did it delay the procedure. The issue was resolved by switching to another bit of the same specification, and the surgery was successfully completed. There was no patient harm.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (b)(4).This report is being submitted pursuant to the provisions of 21 CFR, Part 803 (and/or Part 4, as applicable). This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by DePuy Synthes, or its employees that the report constitutes an admission that the product, DePuy Synthes, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial MedWatch, a Follow-up MedWatch will be filed as appropriate.