FDA Adverse Event
Other
Summary report: N
SCORPION SUTURE PASSER, 16MM
MDR report key: 1032958
·
Received April 22, 2008
Report
- Report Number
- 1220246-2008-00065
- Event Type
- Other
- Date Received
- April 22, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 24, 2008
- Manufacturer
- ARTHREX, INC.
- Product Code
- GAB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVAL CONFIRMED THE TIP HAD BROKEN. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS DEVICE IS DESIGNED TO WITHSTAND FORCES UP TO 10 LBS, AND WHEN USED AS INTENDED, SHOULD NEVER SEE FORCES IN EXCESS OF DESIGN PARAMETERS. THIS EVENT WAS ATTRIBUTED TO MISUSE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HOOK TIP OF THE INSTRUMENT BROKE OFF DURING A SHOULDER CUFF REPAIR. SURGEON REALIZED THE TIP WAS MISSING ONCE HE RETRIEVED THE INSTRUMENT FROM THE PT. THE TIP REMAINS IN THE PT. NO FURTHER PT INFO IS AVAILABLE AND NO ADD'L ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SCORPION SUTURE PASSER, 16MM | SUTURE PASSER | GAB | ARTHREX, INC. | NA | 10286 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |