MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-07-15 for CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES AR-1928SF-S manufactured by Arthrex, Inc..
[20932200]
It was reported that the sutures became loose after implant insertion during a shoulder procedure, rotator cuff repair. The crosspin that holds the sutures through the anchor had broken. The sutures pulled loose and the surgeon could not tie off the knot. The implant was removed but the surgery was delayed over 40 minutes. No further patient information is available and no additional adverse consequences have been reported from this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[21183133]
Review of device history record revealed nothing relevant to this event. Device evaluation revealed signs of misuse. The tip of the anchor is severely bent and twisted and the crosspin is broken off as reported. The observed conditions are typically caused by not inserting the anchor perpendicular to the bone or prying/leveraging the driver. The complainant's event was attributed to misuse.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00134 |
| MDR Report Key | 1077140 |
| Report Source | 05,07 |
| Date Received | 2008-07-15 |
| Date of Report | 2008-06-19 |
| Date of Event | 2008-06-13 |
| Date Mfgr Received | 2008-06-19 |
| Device Manufacturer Date | 2006-10-01 |
| Date Added to Maude | 2009-05-12 |
| 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 | IVETTE GALMEZ, ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES |
| Generic Name | SUTURE ANCHOR DEVICE |
| Product Code | NOV |
| Date Received | 2008-07-15 |
| Returned To Mfg | 2008-06-23 |
| Model Number | NA |
| Catalog Number | AR-1928SF-S |
| Lot Number | 113937 |
| ID Number | NA |
| Device Expiration Date | 2011-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-15 |