FDA Adverse Event
Malfunction
Summary report: N
OASYS ADJUSTABLE DRILL GUIDE
MDR report key: 6169983
·
Received December 13, 2016
Report
- Report Number
- 0009617544-2016-00492
- Event Type
- Malfunction
- Date Received
- December 13, 2016
- Date of Event
- November 14, 2016
- Report Date
- January 27, 2017
- Manufacturer
- STRYKER SPINE-FRANCE
- Product Code
- LXH
- UDI-DI
- 07613327271294
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
LOT# 123191. VISUAL INSPECTION, MATERIAL ANALYSIS, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. THE REPORTED EVENT WAS CONFIRMED VIA VISUAL INSPECTION, WHICH CONFIRMED THE LOCKING PIN HAD FRACTURED OFF OF THE DEVICE. MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. MATERIAL ANALYSIS WAS CONDUCTED, NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. A PLAUSIBLE ROOT CAUSE IS NORMAL WEAR OF THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LOCKING PIN OF THE DRILL GUIDE BROKE OFF DURING SURGERY. MEASURING WITH A K-WIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LOCKING PIN OF THE DRILL GUIDE BROKE OFF DURING SURGERY. MEASURING WITH A K-WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 819772 | OASYS ADJUSTABLE DRILL GUIDE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT. | LXH | STRYKER SPINE-FRANCE | 123191 | 07613327271294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |