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 2020-02-25 for K-LESS T-ROPE W/DRV, SYN REPR, SS AR-8925SS manufactured by Arthrex, Inc..
[187393686]
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
[187393687]
It was reported during a syndesmosis stabilization procedure, while implanting the oblong button on the medial side of the tibia, the button did not properly release from the ar-8925ss syndesmosis tightrope xp inserter. This issue occurred with quantity two ar-8925ss from lot: 10401993. In both instances, the oblong button came back into the tibial tunnel. On the second attempt, the oblong button became wedged in the tunnel and could not be removed. A new ar-8925ss was brought in and used to complete the procedure. Additional information received on 02/06/2020: the rep confirmed the issue was with a quantity two ar-8925ss from lot: 10362311 (x 1) and lot: 10401993 (x 1). The rep stated the first ar-8925ss (lot: 10362311) would not release properly and became stuck and did not fully come off the inserter. The surgeon pulled back, and the button came off the inserter incorrectly and could not be seated appropriately. The surgeon then made a larger incision on the lateral side in order to cut the sutures and retrieve the button. The second ar-8925ss (lot: 10401993) was brought in and the same issue occurred. The button came off the inserter a little bit. Upon pulling back, the button became lodged in the tunnel and the round button on the inserter also came out of its track creating more slack in the tightrope. When the button could not be pulled back through the tunnel, the surgeon used the tightrope xp inserter to attempt to push the oblong button out of the tibial tunnel on the medial side, but it would not move out of the tunnel. The second button was left implanted. The surgeon then drilled a new tunnel and a third ar-8925ss from lot: 10373020 was used to complete the procedure without further issue. The complaint is associated with a primary procedure, and at this time no revision is scheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01696 |
| MDR Report Key | 9750599 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2019-10-07 |
| Date Added to Maude | 2020-02-25 |
| 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 | 2020-02-25 |
| Model Number | K-LESS T-ROPE W/DRV, SYN REPR, SS |
| Catalog Number | AR-8925SS |
| Lot Number | 10401993 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-25 |