FDA Adverse Event
Malfunction
Summary report: N
WASHERLOC CANCELLOUS SCREW
MDR report key: 1051546
·
Received May 16, 2008
Report
- Report Number
- 1825034-2008-00122
- Event Type
- Malfunction
- Date Received
- May 16, 2008
- Date of Event
- July 26, 2006
- Report Date
- July 27, 2006
- Manufacturer
- ARTHROTEK/BIOMET
- Product Code
- MBI
- PMA / PMN Number
- K981967
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. EVAL OF THE RETURNED DEVICE FOUND METAL BURRS LOCATED ON THE CROSS SLOT OF THE SCREW HEAD. THIS CONDITION WOULD PREVENT INSERTION OF THE SCREWDRIVER IN THE SCREW HEAD. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ACL PROCEDURE IN 2006, SCREWDRIVER WOULD NOT FIT INTO THE SCREW HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WASHERLOC CANCELLOUS SCREW | MBI | ARTHROTEK/BIOMET | NA | 181950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |