V. MUELLER
Received Jun 5, 2025 · Event occurred Apr 15, 2025
Report 1527821-2025-00008 · MDR key 22153992
Device
Generic name
Orthopaedic Mallet
Manufacturer
Steris CorporationModel number
OS1519Catalog number
OS1519
Lot number
(10)XSSZ09
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES PIECES OF METAL WERE "FLECKING OFF" OF THEIR ORTHOPAEDIC MALLET. NO REPORT OF INJURY.
Additional Manufacturer Narrative
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative
THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO THE SUPPLIER FOR EVALUATION. UPON EVALUATION, IT WAS FOUND THAT PIECES OF METAL WERE COMING OFF THE DEVICE. THE LIKELY CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO WEAR AND TEAR OF THE INSTRUMENT OVER TIME. THE DEVICE SUBJECT OF THE REPORTED EVENT WAS MANUFACTURED IN 2016 AND IS APPROXIMATELY NINE YEARS OLD. THE INSTRUMENT WAS PERMANENTLY REMOVED FROM SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.