FDA Adverse Event
Malfunction
Summary report: N
FIXATION BOLT 9X50 MM
MDR report key: 2472153
·
Received February 23, 2012
Report
- Report Number
- 9610622-2012-00101
- Event Type
- Malfunction
- Date Received
- February 23, 2012
- Date of Event
- February 15, 2012
- Report Date
- February 15, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
ON (B)(6) 2012, GAMMA3 LONG NAIL OPERATION WAS PERFORMED. WHEN ASSEMBLING THE GAMMA3 TARGET DEVICE AND DTD, FIXATION BOLT COULDN'T BE INSERTED. SURGEON TRIED ANOTHER BOLT, THEN THE ANOTHER BOLT COULD BE INSERTED. AFTER THE OPERATION SALES REP TRIED TO INSERT THE BOLT WHICH FAILED DURING THE OPERATION, THE BOLT COULD BE INSERTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXATION BOLT 9X50 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K283813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |