DEPTH DEVICE, 2.7 / 3.5 / 4.0MM, LOW PRO
Received Feb 20, 2026 · Event occurred Feb 4, 2026
Report 1220246-2026-00701 · MDR key 24401184
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
012443
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6 COMPLAINT ALLEGATION IS CONFIRMED BY THE ATTACHED PICTURE, WHICH SHOWS THE TIP OF THE DEVICE WAS BROKEN OFF. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATEDLY CLEANING PROCESSES AND EXTENDED USE IN THE FIELD.
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 04-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8943-15 DEPTH DEVICE BROKE. NO FURTHER INFORMATION WAS PROVIDED. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO DELAY OR PATIENT HARM. ADDITIONAL INFORMATION WAS PROVIDED BY THE REP ON 06-FEB-26 THAT THIS WAS DISCOVERED DURING AN ANKLE FRACTURE. THE INSTRUMENT WAS NOT USED WITH POWER AND A PIECE SNAPPED OFF BUT THE FRAGMENT WAS RETRIEVED.