FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 2200839
·
Received August 11, 2011
Report
- Report Number
- 1030489-2011-01024
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- October 10, 2010
- Report Date
- April 22, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- HXX
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). VISUAL EXAMINATION CONFIRMED APPROXIMATELY 3MM OR THE TIP IS BROKEN OFF, CONSISTENT WITH INTERFACE DURING USE. FRACTURE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. PLASTIC DEFORMATION IS NOTED BELOW THE FRACTURE SURFACE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE TORX SHAFT WAS BROKEN DURING USE IN SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | SCREWDRIVER | HXX | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | BM09A016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |