MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-08 for PUSHLOCK * manufactured by Arthrex Arthroscopy Instruments, Inc..
[956644]
Patient was undergoing right shoulder arthroscopy and rotator cuff repair. A 4. 5mm push-lock anchor was attempted to be seated when the tip of the anchor became dislodged and was floating around the subacromial space. Attempts were made to suction it out, but it disappeared. Repair of the rotator cuff continued. Before closure, the c-arm was brought in to locate the anchor tip. The suction line was also checked and the tip was found in the filter of the suction tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1164723 |
| MDR Report Key | 1164723 |
| Date Received | 2008-08-08 |
| Date of Report | 2008-08-08 |
| Date of Event | 2008-08-05 |
| Report Date | 2008-08-08 |
| Date Reported to FDA | 2008-08-08 |
| Date Added to Maude | 2008-09-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUSHLOCK |
| Generic Name | SUTURE ANCHOR |
| Product Code | KGS |
| Date Received | 2008-08-08 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 161371 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1188821 |
| Manufacturer | ARTHREX ARTHROSCOPY INSTRUMENTS, INC. |
| Manufacturer Address | 1370 CREEKSIDE BLVD NAPLES FL 341081945 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-08 |