FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1010222
·
Received March 6, 2008
Report
- Report Number
- 1030489-2008-00123
- Event Type
- Malfunction
- Date Received
- March 6, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 11, 2008
- Manufacturer
- MEDTRONIC SOFAMOR DANEK
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED TO MEDTRONIC FOR EVAL. A VISUAL EXAMINATION CONFIRMED THAT THE INSTRUMENT WAS SPLIT AT THE TIP. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE TORQUE LIMITING DRIVER FRACTURED. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | DRIVER | HXX | MEDTRONIC SOFAMOR DANEK | NA | BM05H007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |