FDA Adverse Event
Malfunction
Summary report: N
BIORAPTOR 2.9 SUTURE ANCHOR W/ULTRABRAID
MDR report key: 1070525
·
Received July 1, 2008
Report
- Report Number
- 1219602-2008-00153
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- May 28, 2008
- Report Date
- June 4, 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
EVAL OF THE ANCHOR CONFIRMED ITS CONDITION; IT HAS BROKEN AT THE PROXIMAL AND WHERE IT INTERFACES WITH THE INSERTER. THE BREAK IS MORE OF A TEAR, IT APPEARS THT THE INSERTER WAS TWISTED LIKE A SCREW DRIVER TO INSERT THE ANCHOR.
Description of Event or Problem · 1
DURING SLAP REPAIR AS THE SURGEON PLACED THE BIORAPTOR ANCHOR HE NOTICED IT HAD SPLIT. THIS WAS PRIOR TO USING A MALLET. IT APPEARS THAT THE BROKEN ANCHOR WAS REMOVED. PT HAD NORMAL BONE QUALITY. A 3.0 MM DRILL WAS USED AND AXIAL ALIGNMENT WAS MAINTAINED DURING INSERTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIORAPTOR 2.9 SUTURE ANCHOR W/ULTRABRAID | BIORAPTOR | MBI | SMITH & NEPHEW INC., ENDOSCOPY DIV. | 7210705 | 50207687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |