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 2012-03-02 for STATAK SUTURE ANCHOR WITH ATTACHED SUTURE 00234405000 manufactured by Zimmer, Inc..
[21353002]
Information was received from a foreign source who is not required to complete form 3500a. This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[21456819]
It was reported that the suture was cut at the hole of anchor during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1822565-2012-00435 |
| MDR Report Key | 2501789 |
| Report Source | 01,05,08 |
| Date Received | 2012-03-02 |
| Date of Report | 2012-02-01 |
| Date of Event | 2012-01-31 |
| Date Mfgr Received | 2012-02-01 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-05-01 |
| 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 SUTURE ANCHOR WITH ATTACHED SUTURE |
| Product Code | KGS |
| Date Received | 2012-03-02 |
| Returned To Mfg | 2012-03-01 |
| Catalog Number | 00234405000 |
| Lot Number | 284543 |
| Device Expiration Date | 2016-07-23 |
| 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 | 2012-03-02 |