FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 1083794
·
Received July 25, 2008
Report
- Report Number
- 1030489-2008-00405
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- November 9, 2006
- Report Date
- November 9, 2006
- Manufacturer
- WARSAW ORTHOPEDIC INC
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER WHERE EVAL CONFIRMED THE FRACTURE OF THE INSTRUMENT TIP. NO EVIDENCE WAS NOTED OF MANUFACTURING NON-CONFORMANCE DURING PRODUCT ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE INSTRUMENT BREAKAGE DID NOT RESULT IN PT COMPLICATIONS. NEVERTHELESS, WE ARE FILING AN MDR FOR NOTIFICATION PURPOSES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PROBE WAS BROKEN. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, NO PT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | PROBE | LXH | WARSAW ORTHOPEDIC INC | NA | 01220 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |