FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1083690
·
Received July 24, 2008
Report
- Report Number
- 1030489-2008-00361
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 19, 2008
- Report Date
- June 24, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVAL. VISUAL EXAMINATION CONFIRMED THE INSTRUMENT IS CRACKED AT THE TIP FROM THE SPRING TAB TO THE HEX. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE TORQUE LIMITING DRIVER CRACKED AND WOULD NOT ENGAGE THE SETSCREW. NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | DRIVER | HXX | WARSAW ORTHOPEDIC INC. | NA | BM03K029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |