FDA Adverse Event
Malfunction
Summary report: N
PREDRILLING ASSEMBLY-SHORT APEX 5MM
MDR report key: 2100176
·
Received May 13, 2011
Report
- Report Number
- 8031020-2011-00111
- Event Type
- Malfunction
- Date Received
- May 13, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS SELZACH
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE IN THIS EVENT IS CATALOG NUMBER 5018-6-180, LOT # U15322 SELF-DRILLING HALF, PIN APEX 5MM, 180 X 50MM.
Description of Event or Problem · 1
IT WAS REPORTED, THE SURGEON ATTEMPTED TO INSERT APEX PIN THROUGH DRILL SLEEVE IN QUESTION. THE TOLERANCE BETWEEN THE PIN AND THE DRILL SLEEVE IS INCORRECT BECAUSE THEY GOT STUCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREDRILLING ASSEMBLY-SHORT APEX 5MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS SELZACH | NA | W27339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Other |