FDA Adverse Event
Malfunction
Summary report: N
PRM STM INSRTR EXTRCT
MDR report key: 15885310
·
Received November 30, 2022
Report
- Report Number
- 1038671-2022-01533
- Event Type
- Malfunction
- Date Received
- November 30, 2022
- Date of Event
- April 4, 2022
- Report Date
- March 3, 2023
- Manufacturer
- EXACTECH, INC.
- Product Code
- JXH
- UDI-DI
- 10885862079701
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
SECTION H10: (H3) THE MOSTLY LIKELY UNDERLYING CAUSE FOR THE BROKEN INSTRUMENT REPORTED CANNOT BE DETERMINED AS THE DEVICE APPEARS TO FUNCTION AS INTENDED. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H6) COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE
Additional Manufacturer Narrative · 0
PENDING EVALUATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS INSTRUMENT COULD HAVE BROKEN DURING SURGERY. HOWEVER, THE BREAKAGE HAS BEEN NOTICED AT THE RECOVERY OF THE INSTRUMENTATION-SET BY OUR LOGISTICS DEPT., AFTER THE CLEANING REALIZED BY THE STERILIZATION TEAM OF THE HOSPITAL. NO INFORMATION HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS ISSUE AND XNOV IP DIDN'T RECEIVE ANY REQUEST FOR COMPLEMENTARY INFORMATION REGARDING THIS ISSUE AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2398082 | PRM STM INSRTR EXTRCT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | JXH | EXACTECH, INC. | 301-07-10 | 72726013 | 10885862079701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | UNK. |