FDA Adverse Event
Malfunction
Summary report: N
5.0MM BIOZIP SUT ANCHOR W/ 2 #2 FORCE FIBER SUTURE
MDR report key: 1060990
·
Received June 12, 2008
Report
- Report Number
- 2936485-2008-00051
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- May 14, 2008
- Report Date
- May 16, 2008
- Manufacturer
- STRYKER ENDOSCOPY
- Product Code
- KGS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED, ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE SURGEON USED A 5.0 BIOZIP ANCHOR ON THE LEFT SHOULDER FOR A ROTATOR CUFF SUPRASPINATUS TEAR. THE SUTURE (FORCE FIBER) BROKE. THE SURGEON BACKED OUT THE ANCHOR USING THE ORIGINAL TROCAR TIP INSERTER. HE THEN WENT IN WITH A 6.5 BIOZIP. WHEN HE WAS TYING HIS KNOTS ARTHROSCOPICALLY, THE ANCHOR EYELETS BROKE. HE THEN BACKED OUT OF 6.5. HE TRIED TO USE AN "ARTHRY" BIOCOCK SCREW AND IT PULLED OUT. SO HE DID A MINI-OPEN PROCEDURE AND INSERT ANOTHER BIOCOCKSCREW."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.0MM BIOZIP SUT ANCHOR W/ 2 #2 FORCE FIBER SUTURE | FIBER SUTURE | KGS | STRYKER ENDOSCOPY | 3602268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |