FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1161464
·
Received September 11, 2008
Report
- Report Number
- 1030489-2008-00508
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 13, 2008
- Manufacturer
- WARSAW ORTHOPEDIC INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THAT THE STATIC PORTION OF THE TIP IS BROKEN AT THE PIN LOCATION, SUGGESTING THE USE OF EXCESSIVE FORCE. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PITUITARY WAS BROKEN INTO PIECES DURING USE IN SURGERY. ALL PIECES WERE RECEIVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | PITUITARY | LXH | WARSAW ORTHOPEDIC INC. | NA | GZ06E129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |