MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-07-14 for PUSHLOCK, PEEK, 3.5MM X 14MM AR-1926PS manufactured by Arthrex, Inc..
[879604]
It was reported that during a rotator cuff repair, the surgeon had loaded 2 suture strands through the peek eyelet and the eyelet broke (split). The anchor was removed but the eyelet was left in the bone. No further pt info is available and no additional adverse consequences have been reported from this event. This is the first of two reports submitted for this event. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8023925]
The device was not returned and the complainant's event could not be verified. 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 event could not be determined from the info available and without device eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2008-00129 |
| MDR Report Key | 1079067 |
| Report Source | 05,06,07 |
| Date Received | 2008-07-14 |
| Date of Report | 2008-06-16 |
| Date of Event | 2008-06-16 |
| Date Mfgr Received | 2008-06-16 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2008-10-28 |
| 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 | PUSHLOCK, PEEK, 3.5MM X 14MM |
| Generic Name | IMPLANTABLE DEVICE |
| Product Code | KGS |
| Date Received | 2008-07-14 |
| Model Number | NA |
| Catalog Number | AR-1926PS |
| Lot Number | 140456 |
| ID Number | NA |
| Device Expiration Date | 2013-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1201631 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | NAPLES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-14 |