MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-09 for GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM AR-8816G-02 manufactured by Arthrex, Inc..
[174313413]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[174313434]
It was reported that during an arthroscopic tfcc repair the arthrex devices ar-8816g-02 an ar-8816g were used. The sleeve does not lock into the target device. It's slipping and it's unstable. The patient was already under anesthesia. The surgeon had to cancel the surgery as he had no backup equipment. The second surgery took place on the 17th of december. No further information received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01554 |
| MDR Report Key | 9568981 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-09 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-12-10 |
| Date Mfgr Received | 2019-12-16 |
| Device Manufacturer Date | 2018-04-10 |
| Date Added to Maude | 2020-01-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-09 |
| Model Number | GUIDE SLEEVE, DOUBLE BORE DIAM 1.6MM |
| Catalog Number | AR-8816G-02 |
| Lot Number | 1448174701 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-09 |