HUMERAL RESECTION TEMPLATE, LEFT
Received Nov 26, 2025 · Event occurred Nov 6, 2025
Report 1220246-2025-05217 · MDR key 23657870
Device
Generic name
Manual Instr, General Surgical
Manufacturer
Arthrex, Inc.Model number
HUMERAL RESECTION TEMPLATE, LEFTCatalog number
AR-9200-01L
Lot number
011751
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D9, G3, H3, H6. COMPLAINT ALLEGATION IS CONFIRMED. -VISUAL INSPECTION OF THE HUMERAL RESECTION TEMPLATE, LEFT NOTED THAT THE CLOCKING PIN WAS BROKEN OFF. -FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR DUE TO REPEATED USE OF THE DEVICE 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 11/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9200-01L HUMERAL RESECTION TEMPLATE SCREW BROKE INSIDE THE DEVICE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED BY THE REP ON 11/13/25. THIS WAS DISCOVERED DURING AN RSTA. ALL FRAGMENTS WERE RETRIEVED AND NO POWER WAS USED.