FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 2132498
·
Received June 17, 2011
Report
- Report Number
- 1030489-2011-00747
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 19, 2011
- Manufacturer
- MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FUNCTIONALLY EVALUATED FLEX ARM RIGIDITY BY MANUALLY FULLY TIGHTENING AND MANIPULATING INSTRUMENT TIP. THE INSTRUMENT TIP WAS INSUFFICIENTLY RIGID AFTER FULL TIGHTENING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH ANTICIPATED WEAR DUE TO A WORN INTERNAL CABLE, RESULTING IN THE FOREGOING EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DISKECTOMY THE FLEX ARMS WOULD NOT TIGHTEN. ALTHOUGH THE INSTRUMENTS WERE USED INTRAOPERATIVELY, NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING | NA | MY07K001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |