FDA Adverse Event
Malfunction
Summary report: N
BIORAPTOR AB 2.9 MM
MDR report key: 2152051
·
Received July 7, 2011
Report
- Report Number
- 1219602-2011-00109
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- February 9, 2011
- Report Date
- March 22, 2011
- Manufacturer
- SMITH & NEPHEW ENDOSCOPY
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ONLY THE INSERTER AND SUTURE WERE RETURNED FOR EVALUATION. SUTURE IS FREE FROM THE INSERTER AND HAS NO SIGNS OF DAMAGE. INSERTER SHAFT IS SLIGHTLY BOWED. MEASUREMENT OF THE INSERTER SHAFT CONFIRMED IT WAS MANUFACTURED PRIOR TO (B)(4) WHICH REDUCED THE DIMENSIONS AT THE DISTAL END OF THE SHAFT TO ELIMINATE THE INTERFERENCE BETWEEN THE ANCHOR AND THE INSERTER ON THE 2.9 BIORAPTOR SUTURE ANCHORS. (B)(4).
Description of Event or Problem · 1
BROKEN IMPLANT PRODUCT BROKE INTO THE SHOULDER OF THE PATIENT DURING CASE. PER MALFUNCTION REPORT: PIECE WAS NOT REMOVED FROM PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIORAPTOR AB 2.9 MM | BIORAPTOR 2.9 WITH 2 ULTRABRAID | HWC | SMITH & NEPHEW ENDOSCOPY | 72200775 | 50335473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR |