FDA Adverse Event
Malfunction
Summary report: N
MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
MDR report key: 3033542
·
Received April 3, 2013
Report
- Report Number
- 1030489-2013-00928
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 5, 2013
- Manufacturer
- MSD BARTLETT MFG
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6). (B)(4). LOCATION : HOSPITAL. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE DURING PROVISIONAL TIGHTENING. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136679 | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | MSD BARTLETT MFG | NA | MA06C039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |