FDA Adverse Event
Malfunction
Summary report: N
GRASPERS
MDR report key: 3776411
·
Received April 28, 2014
Report
- Report Number
- 1219602-2014-00142
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- January 15, 2014
- Report Date
- April 1, 2014
- Manufacturer
- MANSFIELD MANUFACTURING SITE
- Product Code
- NBH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS. (B)(4).
Description of Event or Problem · 1
DURING A KNEE ARTHROSCOPY UTILIZING A GRSPR, ALGTR, UPBT, BEFORE CLOSING THE SURGICAL SITE, IT WAS NOTICED THAT A PIECE OF THE PUNCH¿S JAW WAS MISSING. INTRA-ARTICULAR EXPLORATION DID NOT LOCATE THE PIECE. THE LOCATION OF THE PIECE COULD NOT BE ACCESSED UNDER ARTHROSCOPY. A RADIOSCOPY WAS DONE AND THE PIECE WAS SEEN IN THE KNEE AT THE BACK OF THE CONDYLE. DESPITE DIFFICULT EFFORTS, IT WAS IMPOSSIBLE TO REMOVE THIS PIECE. MULTIPLE KNEE MOVEMENTS WERE MADE TRYING TO MOVE THE PIECE; BUT, IT WOULD NOT MOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255405 | GRASPERS | GRSPR,ALGTR,UPBTR | NBH | MANSFIELD MANUFACTURING SITE | 011021 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |