MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for ARM SLEEVE CONNECTOR, S3 AR-1650-02 manufactured by Allen Medical Systems, Inc..
[61459444]
Awaiting the return of the failed device for root cause evaluation, remediation determination and implementation. A follow-up mdr will be filled.
Patient Sequence No: 1, Text Type: N, H10
[61459445]
The pins from the sleeve connector fell out during a labral repair. The patient's arm dropped as a result of the pins coming out. According to the clinical manager at the site, the event took place early in the case, prior to anchor placement, and there was no injury with this event. The procedure was completed in standard fashion, switching to their old lateral traction boom.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221538-2016-00002 |
| MDR Report Key | 6135014 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-18 |
| Date of Event | 2016-11-18 |
| Date Mfgr Received | 2016-11-18 |
| Date Added to Maude | 2016-11-30 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN DRAHOS |
| Manufacturer Street | 100 DISCOVERY WAY |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Manufacturer Phone | 9786350761 |
| Manufacturer G1 | ALLEN MEDICAL SYSTEMS |
| Manufacturer Street | 100 DISCOVERY WAY |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARM SLEEVE CONNECTOR, S3 |
| Generic Name | ARM SLEEVE CONNECTOR |
| Product Code | FMP |
| Date Received | 2016-11-30 |
| Model Number | AR-1650-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 100 DISCOVERY WAY ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-30 |