FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 2100981
·
Received May 24, 2011
Report
- Report Number
- 1030489-2011-00615
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- October 8, 2010
- Report Date
- April 1, 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). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION: THE SCREWDRIVER WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION CONFIRMED APPROXIMATELY 3MM OF THE TIP HAD BROKEN OFF. FRACTURE SURFACE ANALYSIS REVEALED A FAIRLY FLAT, BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW; CONSISTENT WITH TORSIONAL OVERLOAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT 6 MM OF THE TIP OF THE SCREWDRIVER WAS BROKEN OFF. ALTHOUGH THE INSTRUMENT WAS USED INTRAOPERATIVELY, NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | SCREWDRIVER | HXX | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | BM09F015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |