FDA Adverse Event
Malfunction
Summary report: N
SPECIALTY 4.2 X 340MM STEP DRILL-AO T2 INSTRUMENTS PER FILE T0286
MDR report key: 4583288
·
Received March 9, 2015
Report
- Report Number
- 0002249697-2015-00660
- Event Type
- Malfunction
- Date Received
- March 9, 2015
- Date of Event
- February 10, 2015
- Report Date
- February 11, 2015
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS LOST AT THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.
Additional Manufacturer Narrative · 1
(B)(4) AND HAS BEEN REPORTED UNDER MFR REPORT # 0009610622-2016-00213
Description of Event or Problem · 1
4.2MM X 340MM DRILL SNAPPED APPROXIMATELY 40MM FROM TIP WHILE DRILLING THROUGH A T2 SCN OBLIQUE SCREW HOLE. SECTION OF THE DRILL WAS LEFT IT SITU.
Description of Event or Problem · 1
4.2MM X 340MM DRILL SNAPPED APPROXIMATELY 40MM FROM TIP WHILE DRILLING THROUGH A T2 SCN OBLIQUE SCREW HOLE. SECTION OF THE DRILL WAS LEFT IT SITU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162594 | SPECIALTY 4.2 X 340MM STEP DRILL-AO T2 INSTRUMENTS PER FILE T0286 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | STRYKER ORTHOPAEDICS-MAHWAH | K0C919D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |