MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for K-LESS T-ROPE W/DRV, SYN REPR, SS AR-8925SS manufactured by Arthrex, Inc..
[188863807]
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
[188863808]
It was reported during a procedure the surgeon requested a 2-hole stainless steel plate with a quantity two ar-8925ss, tightrope xp's. Although the insertion of the plate and first tightrope went flawlessly, the next two tightropes malfunctioned. The second ar-8925ss (lot: 10448974) was inserted into the proximal hole and pulled through the cortex on the medial side of the tibia. A third ar-8925ss from the same lot was brought in, but the same exact issue occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01768 |
| MDR Report Key | 9883063 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-11-11 |
| 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 | K-LESS T-ROPE W/DRV, SYN REPR, SS |
| Generic Name | WASHER, BOLT NUT |
| Product Code | HTN |
| Date Received | 2020-03-26 |
| Model Number | K-LESS T-ROPE W/DRV, SYN REPR, SS |
| Catalog Number | AR-8925SS |
| Lot Number | 10448974 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-26 |