MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2008-07-16 for STATAK SOFT TISSUE ATTACHMENT DEVICE 00234407200 manufactured by Zimmer, Inc..
[896564]
It is reported that the surgeon attempted to implant the sutures and the threads broke off of the suture attachment.
Patient Sequence No: 1, Text Type: D, B5
[8024432]
Eval summary: the manufacturing records of the returned statak assembly indicate that the suture was securely held in the driver shaft without any damage to the threads. Inspection reports also indicate no sign of damage, and the suture was properly assembled to the anchor. The fracture condition of the sutures cannot be analyzed since they were not returned with the driver shaft. The actual cause cannot be determined with the available information. Device history records indicate device manufactured to specification. The returned product meets specification where measurable in its returned condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2008-00423 |
| MDR Report Key | 1079947 |
| Report Source | 05,08 |
| Date Received | 2008-07-16 |
| Date of Report | 2008-06-12 |
| Date Facility Aware | 2008-06-12 |
| Report Date | 2008-06-12 |
| Date Mfgr Received | 2008-06-18 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2008-10-10 |
| 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 RECKTENWALL |
| 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 ATTACHMENT DEVICE |
| Product Code | KGS |
| Date Received | 2008-07-16 |
| Returned To Mfg | 2008-06-18 |
| Model Number | NA |
| Catalog Number | 00234407200 |
| Lot Number | BBC68785 |
| ID Number | NA |
| Device Expiration Date | 2011-09-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1214277 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-16 |