FDA Adverse Event
Malfunction
Summary report: N
STRYKER INSTRUMENTS
MDR report key: 145803
·
Received January 22, 1998
Report
- Report Number
- 145803
- Event Type
- Malfunction
- Date Received
- January 22, 1998
- Date of Event
- December 10, 1997
- Report Date
- December 23, 1997
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT IN OUTPATIENT SURGERY FOR MANDIBULAR PROCEDURE. POST CLOSURE OF SURGICAL WOUND SAW BLADE (#296-34-102) NOTED TO BE BROKEN AND MISSING BLADE PORTION OF INFERIOR BORDER SAW BLADE. MD NOTIFIED, X-RAY ORDERED. BLADE VISIBLE ON X-RAY ORDERED. BLADE VISIBLE ON X-RAY ON PT'S RIGHT SIDE OF MOUTH. PT REINTUBATED AND SUTURES REMOVED AND BLADE PORTION REMOVED. MISSING PIECE RETRIEVED AND ALL PORTIONS ACCOUNTED FOR BY MD. PT TO PACU WITHOUT FURTHER COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER INSTRUMENTS | MICROSURGICAL SAW | GFA | STRYKER INSTRUMENTS | 296-34-102 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other | FURTHER INTERVENTIONS REQUIRED.| IMMEDIATE RETRIEVAL OF BLADE PORTION WITH NO |