FDA Adverse Event
Malfunction
Summary report: N
ORHTOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 1911501
·
Received December 1, 2010
Report
- Report Number
- 1030489-2010-01517
- Event Type
- Malfunction
- Date Received
- December 1, 2010
- Date of Event
- November 2, 2010
- Report Date
- November 2, 2010
- Manufacturer
- WARSAW ORTHOPEDIC, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THE DRIVER WAS RETURNED FOR EVALUATION. APPROXIMATELY ~3MM OF TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALED FAIRLY FLAT, BRITTLE FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGERY. THE PATIENT UNDERWENT A REVISION SURGERY TO EXPAND THE CONSTRUCT TO AN ADJACENT LEVEL. IT WAS REPORTED THAT THE DRIVER TIP BROKE DURING THE REVISION SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORHTOPEDIC MANUAL SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | WARSAW ORTHOPEDIC, INC. | NA | JM00851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Congenital Anomaly |