FDA Adverse Event
Malfunction
Summary report: N
SCREWDRIVER 2.5 MM
MDR report key: 2366037
·
Received November 4, 2011
Report
- Report Number
- 9610622-2011-00542
- Event Type
- Malfunction
- Date Received
- November 4, 2011
- Date of Event
- May 16, 2011
- Report Date
- October 12, 2011
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
LOT#: K816151. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
A RESIDENT AT THE HOSPITAL REPORTED THE FOLLOWING EVENT: "DURING A SURGERY (IMPLANTATION OF A SEIDEL HUMERAL NAIL) WHILE UNLOCKING THE SCREW, THE SCREWDRIVER BROKE. ANOTHER SCREWDRIVER WAS USED AND ALSO BROKE. A JACOB HANDLE WAS THEREFORE USED TO UNLOCK THE SCREW, WHICH DELAYED THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCREWDRIVER 2.5 MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | K114707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |