MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2008-02-29 for SUTURE BUTTON 3.5MM, STERILE AR-8920 manufactured by Arthrex, Inc..
[800803]
It was reported that during an anterior cruciate ligament repair, the suture broke as the surgeon was passing the suture through the button. The surgery was delayed approximately 45 minutes but no add'l adverse consequences were reported with the pt. The surgery was completed with a different product. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8028741]
Device evaluation revealed that only the button was returned. A new suture from stock was used to test and passed through the button without problems. The suture remained intact. The button had deep scratches and gouges which evidence contact with a sharp object. The cause of the complainant's event, however, could not be determined from the info available and without evaluation of the actual suture involved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00026 |
| MDR Report Key | 1005055 |
| Report Source | 06,07 |
| Date Received | 2008-02-29 |
| Date of Report | 2008-02-05 |
| Date of Event | 2008-02-05 |
| Date Mfgr Received | 2006-02-05 |
| Device Manufacturer Date | 2007-08-01 |
| Date Added to Maude | 2008-09-02 |
| 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, SENIOR ANALYST |
| Manufacturer Street | 1370 CREEKSIDE BLVD. |
| 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 | SUTURE BUTTON 3.5MM, STERILE |
| Generic Name | IMPLANTABLE DEVICE |
| Product Code | KGS |
| Date Received | 2008-02-29 |
| Returned To Mfg | 2008-02-25 |
| Model Number | NA |
| Catalog Number | AR-8920 |
| Lot Number | 138043 |
| ID Number | NA |
| Device Expiration Date | 2012-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1002933 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-02-29 |