FDA Adverse Event
Malfunction
Summary report: N
SCR BIORCI-HA 9X30 STERILE
MDR report key: 7026855
·
Received November 13, 2017
Report
- Report Number
- 1219602-2017-01399
- Event Type
- Malfunction
- Date Received
- November 13, 2017
- Date of Event
- October 31, 2017
- Report Date
- December 28, 2017
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- MAI
- UDI-DI
- 03596010460011
- PMA / PMN Number
- K002274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CLINICAL DETAILS WERE REVIEWED, AND IT WAS IDENTIFIED THAT THE SURGICAL SITE WAS NOT PREPARED WITH A STARTER. PER THE DEVICE BIORCI IFU 1061039 ¿ WARNING: THE STARTER MUST BE UTILIZED WITH THE BIORCI¿HA SCREWS TO MINIMIZE SCREW BREAKAGE DURING INSERTION¿.
Description of Event or Problem · 1
IT WAS REPORTED THAT BIORCI SCREW BROKE DURING THE INTERVENTION. NO PATIENT INJURY WAS REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806313 | SCR BIORCI-HA 9X30 STERILE | FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE | MAI | SMITH & NEPHEW, INC. | 7207682 | 50652157 | 03596010460011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |