MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-06-12 for 5.0MM BIOZIP SUT ANCHOR W/ 2 #2 FORCE FIBER SUTURE 3910200025 manufactured by Stryker Endoscopy.
[869932]
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. "
Patient Sequence No: 1, Text Type: D, B5
[8020255]
Additional info will be provided, once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2008-00051 |
| MDR Report Key | 1060990 |
| Report Source | 07 |
| Date Received | 2008-06-12 |
| Date of Report | 2008-05-16 |
| Date of Event | 2008-05-14 |
| Date Mfgr Received | 2008-05-16 |
| Date Added to Maude | 2009-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER SCOTT |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5.0MM BIOZIP SUT ANCHOR W/ 2 #2 FORCE FIBER SUTURE |
| Generic Name | FIBER SUTURE |
| Product Code | KGS |
| Date Received | 2008-06-12 |
| Catalog Number | 3910200025 |
| Lot Number | 3602268 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-12 |