LOW PROFILE OSTEOTOME SHORT 12 MM
Received Feb 19, 2026 · Event occurred Jan 28, 2026
Report 1220246-2026-00665 · MDR key 24387447
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
LOW PROFILE OSTEOTOME SHORT 12 MMCatalog number
AR-13203-12
Lot number
1068642217
Product problems
- Use of Device Problem
Patient
NA · 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 03-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-13203-12 OSTEOTOME WAS DAMAGED DURING USE. DISCOVERED DURING REPROCESSING WITH NO PATIENT EFFECT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6 COMPLAINT ALLEGATION IS CONFIRMED BY THE ATTACHED PICTURE, WHICH SHOWS ONE OF THE ENDS OF THE DEVICE WAS BENT/DAMAGED. 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 RESULTING FROM REPEATED PRYING/LEVERAGING, AND EXTENDED USE OF THE DEVICE IN THE FIELD.