MalfunctionHTJ
DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Received Jun 12, 2026 · Event occurred May 27, 2026
Report 1220246-2026-03372 · MDR key 25484062
Device
Generic name
Depth Gauge
Manufacturer
Arthrex, Inc.Model number
DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PROCatalog number
AR-8943-15
Lot number
012511
Product problems
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 27-MAY-2026, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE AR-8943-15 DEPTH DEVICE BROKE AT THE WELD POINT. THIS ISSUE WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.