MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-15 for SCORPION-MULTIFIRE NEEDLE AR-13995N manufactured by Arthrex, Inc..
[175063466]
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
[175063467]
It was reported that the ar-13995n multifire scorpion needle broke while passing through an aflex 301 graft and the surgeon was unable to retrieve the broken fragment from the graft, but the case was completed. There was not an arthrex sales representative during the procedure. A additional information received on 01/14/2020: the procedure taking place was rotator cuff repair with possible allograft augmentation. The surgeon attempted to retrieve the broken fragment by using a grasper and suture retriever. The lot number of the scorpion is unknown. The rep reported it is unknown whether the needle was dry-fired once or deployed prior to use in surgery. The total number of passes attempted using the needle in the event is unknown. The jaws were securely clamped on the tissue during suture passing, and the needle did not hit bone or inside the cannula. The case was completed by using a new scorpion needle. There are not any portions of the broken needle available to return for evaluation as it was discarded. The rep reported at this time a revision/removal procedure is not scheduled or planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01578 |
| MDR Report Key | 9590540 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2019-12-26 |
| Device Manufacturer Date | 2019-09-02 |
| Date Added to Maude | 2020-01-15 |
| 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 | 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 | SCORPION-MULTIFIRE NEEDLE |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-01-15 |
| Model Number | SCORPION-MULTIFIRE NEEDLE |
| Catalog Number | AR-13995N |
| Lot Number | 10366829 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-15 |