FDA Adverse Event
Malfunction
Summary report: N
ASPEN SURGICAL PRODUCTS - BARD PARKER BLADES
MDR report key: 2310555
·
Received October 17, 2011
Report
- Report Number
- 1836161-2011-00003
- Event Type
- Malfunction
- Date Received
- October 17, 2011
- Report Date
- October 3, 2011
- Manufacturer
- ASPEN SURGICAL PRODUCTS
- Product Code
- GES
- PMA / PMN Number
- PREAMEND
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE COULD NOT BE EVALUATED AS IT WAS NOT RETURNED; NOR WERE ANY OTHER SURGICAL BLADES FROM THE MEDICAL CENTER RETURNED. THE LOT NUMBER FOR THE DEVICE THAT REPORTEDLY FAILED IS UNKNOWN. WE ARE UNABLE TO DETERMINE MANUFACTURE DATE WITHOUT LOT NUMBER. THIS FAILURE IS ATYPICAL AND, WITHOUT NECESSARY INFORMATION FOR A PROPER INVESTIGATION, THE TRUE ROOT CAUSE CANNOT BE DETERMINED.
Description of Event or Problem · 1
DURING A REPAIR OF A ROTATOR CUFF TEAR, THE BLADE BARD PARKER STAINLESS STEEL, SIZE 11, P/N 371211, LOT NUMBER UNKNOWN, BROKE INTO A COUPLE PIECES. ONE PIECE, THE SHARP TIP, WAS LEFT IN THE JOINT AS IT WAS DETERMINED THAT WOULD BE THE BEST COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASPEN SURGICAL PRODUCTS - BARD PARKER BLADES | #11 STAINLESS STEEL SURGICAL BLADE | GES | ASPEN SURGICAL PRODUCTS | 371211 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |