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 2020-03-26 for SCORPION-MULTIFIRE NEEDLE AR-13995N manufactured by Arthrex, Inc..
[185894574]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The device was reported to have been discarded. 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
[185894575]
It was reported that during a rotator cuff repair, when the surgeon was passing the suture, the scorpion needle, ar-13995n, broke. A new scorpion needle, ar-13995n, was used to completed the case. No further information provided. Additional information received on 03/04/2020: the rep reported the lot number of the mating part is unknown. The ar-13995n was not dry fired, and was used only to pass two stitches. The total number of passes was four, and the jaws of the scorpion were fully clamped. The tip of the needle broke as the suture was being passed. The rep reported the broken distal tip of the needle was left in the patient. Additional information received on 03/09/2020: the rep reported the complaint device was discarded and will not be returning for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01765 |
| MDR Report Key | 9882885 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-07-17 |
| Date Added to Maude | 2020-03-26 |
| 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 | 2020-03-26 |
| Model Number | SCORPION-MULTIFIRE NEEDLE |
| Catalog Number | AR-13995N |
| Lot Number | 10337970 |
| 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 | 2020-03-26 |