FDA Adverse Event
Malfunction
Summary report: N
TARGETING ARM T2 PROX. HUM.
MDR report key: 2904779
·
Received December 4, 2012
Report
- Report Number
- 9610622-2012-00554
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 13, 2012
- Report Date
- November 16, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- 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 ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 1806-2025 NAIL ADAPTER T2 PROX. HUM. LOT # UNK; 1806-0163 NAIL HOLDING SCREW, HUMERUS T2 HUMERUS 10MM LOT # UNK; 1806-2030 NUT T2 PROX. HUM LOT # UNK; 1806-0210 DRILL SLEEVE, SHORT T2 TIBIA 5MM LOT # UNK; 1806-3545, DRILL, TRI-FLAT T2 HUMERUS 3.5X230MM LOT # UNK; 1832-38XXS PROXIMAL HUMERAL NAIL LONG, RIGHT T2 PROX. HUM. LOT # UNK.
Description of Event or Problem · 1
DURING T2PH SURGERY WHEN THE SURGEON CHECKED THE ALIGNMENT OF THE NAIL AND THE DEVICE, THE DRILL COULD NOT GO THROUGH THE THIRD HOLE OF THE NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGETING ARM T2 PROX. HUM. | INSTRUMENT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | KHI113175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other |