MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2007-09-21 for BIO-PUSHLOCK 3.5MM X 14MM AR-1926B manufactured by Arthrex, Inc..
[790355]
Customer reports: the device broke in the pt's right shoulder while it was being implanted into the glenoid. The loose pieces were retrieved and removed arthroscopically in conjuction with the scheduled procedure. Further communication with the hosp indicates no adverse consequences were reported with the pt. This device is used for treatment.
Patient Sequence No: 1, Text Type: D, B5
[8094336]
The device has been returned and investigation is in progress. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220246-2007-00196 |
| MDR Report Key | 979217 |
| Report Source | 00,06 |
| Date Received | 2007-09-21 |
| Date of Report | 2007-08-24 |
| Date of Event | 2007-07-13 |
| Date Mfgr Received | 2007-08-24 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2008-01-16 |
| 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 | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIO-PUSHLOCK 3.5MM X 14MM |
| Generic Name | BIO-ABSORBABLE IMPLANT |
| Product Code | KGS |
| Date Received | 2007-09-21 |
| Returned To Mfg | 2007-09-14 |
| Model Number | NA |
| Catalog Number | AR-1926B |
| Lot Number | 124287 |
| ID Number | NA |
| Device Expiration Date | 2009-04-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 947014 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | * NAPLES FL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-09-21 |