FDA Adverse Event
Malfunction
Summary report: N
1/8" PEG DRILL
MDR report key: 4221405
·
Received November 3, 2014
Report
- Report Number
- 0002249697-2014-04105
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 8, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- PMA / PMN Number
- K123486
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
OPERATOR OF THE DRILL CAME AT AN ANGLE INSTEAD OF STRAIGHT THRU THROUGH THE MCBRIDE SIZER AND THE DRILL BIT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701006 | 1/8" PEG DRILL | INSTRUMENT | MBH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |