MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 2008-05-22 for SMALL BONE FAS TAK, TAPERED NEEDLE WITH #2-0 FIBERWIRE AR-1322-752SF manufactured by Arthrex Inc..
[862875]
It was reported that the fiberwires in the anchors broke during implantation. The sutures were discarded but the metal anchors were left intact in the pt. The surgery was delayed over 30 minutes but no additional adverse consequences were reported from this event. No further pt info is available from the customer. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8021808]
The devices were not returned for eval and the customer's complaint could not be verified. Review of the device history record revealed nothing relevant to this event. This is the first complaint of this type for this part/lot combination. The cause of the complainant's event could not be determined from the info available and without device eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00094 |
| MDR Report Key | 1051787 |
| Report Source | 01,05,07,08 |
| Date Received | 2008-05-22 |
| Date of Report | 2008-04-23 |
| Date of Event | 2008-01-01 |
| Date Mfgr Received | 2008-04-23 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2009-04-29 |
| 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 | SMALL BONE FAS TAK, TAPERED NEEDLE WITH #2-0 FIBERWIRE |
| Generic Name | SUTURE ANCHOR DEVICE |
| Product Code | NOV |
| Date Received | 2008-05-22 |
| Model Number | NA |
| Catalog Number | AR-1322-752SF |
| Lot Number | 140278 |
| ID Number | NA |
| Device Expiration Date | 2012-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-22 |