FDA Adverse Event
Malfunction
Summary report: N
ALLTHREAD PEEK ANCHOR
MDR report key: 1250583
·
Received December 5, 2008
Report
- Report Number
- 1825034-2008-00297
- Event Type
- Malfunction
- Date Received
- December 5, 2008
- Date of Event
- November 5, 2008
- Report Date
- November 10, 2008
- Manufacturer
- BIOMET SPORTS MEDICINE, INC.
- Product Code
- HWC
- PMA / PMN Number
- K060693
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT SHOULDER PROCEDURE UTILIZING ALLTHREAD PEEK ANCHORS IN 2008. DURING PROCEDURE, THE FIRST ANCHOR WAS IMPLANTED BUT THE INSERTER SHAFT COULD NOT BE REMOVED FROM THE ANCHOR, AND ANCHOR WAS REMOVED. SECOND ANCHOR WAS IMPLANTED, AGAIN DIFFICULTY WAS EXPERIENCED REMOVING THE INSERTER SHAFT FROM THE ANCHOR, BUT WAS ABLE TO BE LOOSENED AND ANCHOR WAS USED TO COMPLETE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLTHREAD PEEK ANCHOR | FIXATION, SCREW | HWC | BIOMET SPORTS MEDICINE, INC. | N/A | 306850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |