FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1070065
·
Received July 3, 2008
Report
- Report Number
- 1030489-2008-00315
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- May 30, 2008
- Report Date
- June 5, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO MEDTRONIC FOR EVALUATION. MARKINGS ON THE INSTRUMENT SHOW THAT THE DRIVER FAILED IN THE TIGHTENING DIRECTION. CAUSE OF THE FAILURE IS UNKNOWN. 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 HEX QUICK CONNECT SCREWDRIVER WAS BROKEN OFF INSIDE THE SCREW HEAD DURING TIGHTENING. THE BROKEN TIP WAS NOT RETRIEVED AND REMAINS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | SCREWDRIVER | HXX | WARSAW ORTHOPEDIC INC | NA | JM00611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |