FDA Adverse Event
Malfunction
Summary report: N
ACCULIF PL INSERTION HANDLE
MDR report key: 5485512
·
Received March 8, 2016
Report
- Report Number
- 3004024955-2016-00022
- Event Type
- Malfunction
- Date Received
- March 8, 2016
- Date of Event
- February 10, 2016
- Report Date
- February 10, 2016
- Manufacturer
- STRYKER SPINE-US
- Product Code
- LXH
- UDI-DI
- 07613327105926
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD: VISUAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE RETURNED DEVICE WAS CONFIRMED TO HAVE A FRACTURED WELD ON THE DISTAL TIP UPON VISUAL INSPECTION. NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED AS ALL RELEASED UNITS MET STRYKER SPECIFICATIONS. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE IDENTIFIED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF AN INSERTER SEPARATED FROM THE INSTRUMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF AN INSERTER SEPARATED FROM THE INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143183 | ACCULIF PL INSERTION HANDLE | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER SPINE-US | 05061401-6 | 07613327105926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |