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 2008-06-06 for STATAK SOFT TISSUE ATTACHMENT DEVICE 00234405000 manufactured by Zimmer, Inc..
[871461]
It is reported that during surgery in 2008, the suture was not attached to the anchor because it had broken. Surgery was completed with another device.
Patient Sequence No: 1, Text Type: D, B5
[8024268]
This report will be amended, when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00301 |
| MDR Report Key | 1058430 |
| Report Source | 01,05,08 |
| Date Received | 2008-06-06 |
| Date of Report | 2008-05-08 |
| Date of Event | 2008-04-23 |
| Date Facility Aware | 2008-05-08 |
| Report Date | 2008-05-08 |
| Date Mfgr Received | 2008-05-08 |
| Device Manufacturer Date | 2007-11-01 |
| Date Added to Maude | 2009-04-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANN RECTENWALL |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 5743718028 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STATAK SOFT TISSUE ATTACHMENT DEVICE |
| Generic Name | SUTURE ANCHOR WITH ATTACHED SUTURE |
| Product Code | KGS |
| Date Received | 2008-06-06 |
| Returned To Mfg | 2008-05-29 |
| Model Number | NA |
| Catalog Number | 00234405000 |
| Lot Number | BBC92538 |
| ID Number | NA |
| Device Expiration Date | 2007-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-06 |