MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-03 for SCORPION NEEDLE, KNEE AR-12990N manufactured by Arthrex, Inc..
[188655560]
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
[188655561]
It was reported that during a meniscal repair procedure, the scorpion needle, ar-12990n, tip broke in the joint of the patient. The surgeon tried to retrieve all visible broken fragments, however, the surgeon could not confirm if he had retrieved all of the broken fragments. No further information provided. Additional information provided 1/28/2020: the case was completed by using the same device, as the device broke in the last pass and the surgeon was able to sew with no issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01642 |
| MDR Report Key | 9659103 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-03 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2020-02-03 |
| 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 NEEDLE, KNEE |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-02-03 |
| Model Number | SCORPION NEEDLE, KNEE |
| Catalog Number | AR-12990N |
| Lot Number | 10326088 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-02-03 |