FDA Adverse Event
Malfunction
Summary report: N
MATTA IM CANAL FINDERMANUAL SURGICAL INSTRUMENT FOR GENERAL USE
MDR report key: 16713495
·
Received April 11, 2023
Report
- Report Number
- 3004776227-2023-02100
- Event Type
- Malfunction
- Date Received
- April 11, 2023
- Date of Event
- August 1, 2021
- Report Date
- March 29, 2023
- Manufacturer
- SYMMETRY MEDICAL MANUFACTURING INC
- Product Code
- HTR
- UDI-DI
- 00847538010664
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DID A TOTAL HIP CASE TODAY WITH THE SURGEON AND DURING THE CASE A MATTA IM CANAL FINDER BROKE OFF IN THE PATIENTS FEMORAL CANAL. AFTER AN HOUR AND A HALF, WE GOT THE BROKEN INSTRUMENT OUT OF THE PATIENTS FEMORAL CANAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: AN HOUR AND A HALF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374475 | MATTA IM CANAL FINDERMANUAL SURGICAL INSTRUMENT FOR GENERAL USE | RASP | HTR | SYMMETRY MEDICAL MANUFACTURING INC | 259807013 | SO2051853 | 00847538010664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |