FDA Adverse Event
Malfunction
Summary report: N
V. MUELLER
MDR report key: 22153992
·
Received June 5, 2025
Report
- Report Number
- 1527821-2025-00008
- Event Type
- Malfunction
- Date Received
- June 5, 2025
- Date of Event
- April 15, 2025
- Report Date
- June 5, 2025
- Manufacturer
- STERIS CORPORATION
- Product Code
- GFJ
- UDI-DI
- 10885403188305
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Additional Manufacturer Narrative · 0
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.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES PIECES OF METAL WERE "FLECKING OFF" OF THEIR ORTHOPAEDIC MALLET. NO REPORT OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 603693 | V. MUELLER | ORTHOPAEDIC MALLET | GFJ | STERIS CORPORATION | OS1519 | (10)XSSZ09 | 10885403188305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |