MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2014-06-04 for STATAK SOFT TISSUE ANCHOR 00234407200 manufactured by Zimmer, Inc..
[16307040]
It is reported that two stataks were drilled into the pt and would not release, leaving sutures behind. The surgeon had to leave part of th stataks implanted in the pt and use a different statak.
Patient Sequence No: 1, Text Type: D, B5
[16382379]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2014-00695 |
| MDR Report Key | 3978742 |
| Report Source | 01,05,08 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-13 |
| Date of Event | 2014-05-02 |
| Date Mfgr Received | 2014-05-13 |
| Device Manufacturer Date | 2011-09-01 |
| Date Added to Maude | 2014-08-13 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | PO BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATAK SOFT TISSUE ANCHOR |
| Product Code | KGS |
| Date Received | 2014-06-04 |
| Catalog Number | 00234407200 |
| Lot Number | 298576 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | PO BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |