FDA Adverse Event
Malfunction
Summary report: N
BIORAPTOR 2.9 SUTURE ANCHOR W/TWO SUTURES
MDR report key: 1012741
·
Received March 12, 2008
Report
- Report Number
- 1219602-2008-00059
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- October 29, 2007
- Report Date
- February 13, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LOT # PROVIDED CANNOT BE VERIFIED THEREFORE, THE AGE, MFR DATE AND EXP DATE ARE UNK. NO PROD IS BEING RETURNED FOR EVAL.
Description of Event or Problem · 1
DURING A SLAP REPAIR, THE SURGEON DRILLED AN INSERTION SITE ON THE EDGE OF THE GLENOID. THEN THE BIORAPTOR ANCHOR WAS INSERTED INTO THE HOLE. AFTER TAPPING ON THE TOP OF THE INSERTED TWICE TO POUND THE ANCHOR INTO THE INSERTION SITE, THE BIORAPTOR ANCHOR SNAPPED IN HALF. ONLY HALF OF THE ANCHOR WAS INSERTED INTO THE INSERTION SITE. IT WAS NOT POSSIBLE TO REMOVE THE BOTTOM HALF OF THE ANCHOR OUT OF THE BONE. A BACK-UP DEVICE WAS AVAILABLE. A DELAY OF FIFTEEN MINS RESULTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIORAPTOR 2.9 SUTURE ANCHOR W/TWO SUTURES | BIORAPTOR | MBI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7210706 | 5023084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR |