FDA Adverse Event
Malfunction
Summary report: N
ASPEN SURGICAL PRODUCTS - BARD PARKER BLADE
MDR report key: 2427848
·
Received January 12, 2012
Report
- Report Number
- 1836161-2011-00008
- Event Type
- Malfunction
- Date Received
- January 12, 2012
- Date of Event
- November 15, 2011
- Report Date
- December 30, 2011
- Manufacturer
- ASPEN SURGICAL PRODUCTS
- Product Code
- GES
- PMA / PMN Number
- PREAMENDMENT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE COULD NOT BE EVALUATED AS IT WAS NOT RETURNED, NOR WERE ANY OTHER SURGICAL BLADES FROM THE FACILITY. A REVIEW OF MFG RECORDS FROM THE LOT NUMBER PROVIDED REVEALED NO ISSUES OCCURRED DURING PRODUCTION. THIS FAILURE IS ATYPICAL AND WITHOUT NECESSARY INFO FOR A PROPER INVESTIGATION, THE TRUE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem · 1
(B)(4). DURING HIP RESURFACING #10 BLADE BROKE INTO TWO PIECES. BOTH PIECES WERE RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASPEN SURGICAL PRODUCTS - BARD PARKER BLADE | BARD PARKER SURGICAL #10 BLADE | GES | ASPEN SURGICAL PRODUCTS | 371110 | 0000122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |