MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2007-11-14 for CORKSCREW II SUTURE ANCHOR, 5X15MM AR-1902SF manufactured by Arthrex, Inc..
[19551794]
It was reported that the patient presented with an infection (staphylococcus epidermidis) in the shoulder post mini-open rotator cuff repair. Further patient information was requested without success. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[19740337]
The device remains implanted in the patient; therefore, a definitive conclusion could not determined from the information available. Device history review revealed no issues with the sterilization of this lot. This is the second complaint of this nature for the part/lot combination from the same surgeon/hospital. Based on previous evaluations, infection cases are usually hospital acquired, not a product related issue. The type of organism identified in this patient is a pathogen responsible for common nosocomial infections.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2007-00246 |
| MDR Report Key | 946513 |
| Report Source | 01,07,08 |
| Date Received | 2007-11-14 |
| Date of Report | 2007-10-23 |
| Date of Event | 2007-09-04 |
| Date Mfgr Received | 2007-10-23 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-11-19 |
| 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, SR 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 | CORKSCREW II SUTURE ANCHOR, 5X15MM |
| Generic Name | SUTURE ANCHOR DEVICE |
| Product Code | KGS |
| Date Received | 2007-11-14 |
| Model Number | NA |
| Catalog Number | AR-1902SF |
| Lot Number | G10000 |
| ID Number | NA |
| Device Expiration Date | 2011-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 920212 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-11-14 |