MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2012-11-28 for STATAK SOFT TISSUE ANCHOR 00234405000 manufactured by Zimmer, Inc..
[21416600]
It is reported that the surgeon inserted the anchor into the pt's hand, and then noticed there was no suture attached to it. The surgeon removed the anchor and finished the procedure with a new anchor.
Patient Sequence No: 1, Text Type: D, B5
[21487212]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2012-02428 |
| MDR Report Key | 2861540 |
| Report Source | 05,08 |
| Date Received | 2012-11-28 |
| Date of Report | 2012-10-30 |
| Date of Event | 2012-10-09 |
| Date Mfgr Received | 2012-10-30 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2013-01-29 |
| 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 |
| Generic Name | SOFT TISSUE ANCHOR |
| Product Code | KGS |
| Date Received | 2012-11-28 |
| Returned To Mfg | 2012-11-05 |
| Catalog Number | 00234405000 |
| Lot Number | 291338 |
| 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 | 2012-11-28 |