FDA Adverse Event
Malfunction
Summary report: N
STRATAFIX KNOTLESS TISSUE CONTROL DEVICE
MDR report key: 3894622
·
Received February 19, 2014
Report
- Report Number
- 3008845715-2014-00003
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 17, 2014
- Manufacturer
- SURGICAL SPECIALTIES PUERTO RICO INC.
- Product Code
- NEW
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. METHOD, RESULTS AND CONCLUSIONS: THE ACTUAL DEVICE WILL NOT BE RETURNED. NO PRODUCT EVALUATION CAN BE PERFORMED. WITHOUT THE FINISHED GOOD ITEM/LOT NUMBER, IT IS NOT CERTAIN IF THERE WERE ANY QUALITY ISSUES AGAINST THE NEEDLE COMPONENT OR THE FINISHED GOOD LOT. (B)(4). ITEM NUMBER AND FINISHED GOOD LOT NUMBER - UNK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PA WAS CLOSING THE SUBCUTANEOUS TISSUE FOR A TOTAL KNEE. THE KNEE WAS FLEXED. APPROXIMATELY 3/4 OF THE WAY THROUGH, THE NEEDLE BROKE. BOTH PIECES WERE RETRIEVED. FREE NEEDLE WAS USED TO COMPLETE THE CLOSURE, WHICH ALSO BROKE IN THIS TISSUE. NO PT CONSEQUENCES REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106225 | STRATAFIX KNOTLESS TISSUE CONTROL DEVICE | BARBED MATERIAL/ NEEDLES | NEW | SURGICAL SPECIALTIES PUERTO RICO INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention | NONE MADE AVAILABLE |