FDA Adverse Event
Malfunction
Summary report: N
FAST-FIX 360
MDR report key: 3143417
·
Received June 3, 2013
Report
- Report Number
- 1219602-2013-00122
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- March 15, 2013
- Report Date
- May 14, 2013
- Manufacturer
- SMITH & NEPHEW MANSFIELD MANUFACTURING SITE
- Product Code
- GAT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING AN ACL RECONSTRUCTION THE SURGEON WAS UTILIZING A FAST-FIX 360 CURVED NEEDLE DELIVERY SYSTEM, AFTER DEPLOYING T1 AND UPON REMOVING THE INSERTION NEEDLE, IT WAS NOTED THAT THE SUTURE TIED TO T1 AND T2 WAS BROKEN. AS A RESULT, T1 WAS LEFT IN THE PATIENT UNSUPPORTED. THE PROCEDURE WAS ULTIMATELY COMPLETED WITH A BACKUP DEVICE ON HAND. NO PATIENT COMPLICATIONS OR INJURIES WERE REPORTED. THE DEVICE WAS REPORTEDLY DISCARDED POST-OPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244749 | FAST-FIX 360 | FAST-FIX 360 CURVED NDL DELIVERY SYS | GAT | SMITH & NEPHEW MANSFIELD MANUFACTURING SITE | 50444626 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |