MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-04 for MINI TIGHTROPE REPAIR AR-8911DS manufactured by Arthrex, Inc..
[187931930]
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
[187931931]
It was reported by a patient's relative that the patient had undergone a hallux varus procedure using an arthrex tightrope several months prior. The patient's relative indicated that the tightrope construct is believed to be broken. Patient is scheduled for a second surgery on (b)(6) 2019. Patient's relative did not have further details but provided contact information for the patient. Additional information obtained 10/15/2019: patient confirmed revision surgery took place on (b)(6) 2019. Patient is working on obtaining and providing medical records. Part number is still pending from the expected medical records. Patient expects to have all medical records by the end of (b)(6) 2019 after the final post-op appointment. The medical records indicate that the tightrope construct initially corrected a hallux varus deformity which was caused by the patient's two prior bunion surgeries. There is no evidence that the bunion returned. According to the records the tightrope lost correction which led to the great toe moving back to the prior varus position. Additional information obtained 1/9/2020: patient provided medical records which contain the arthrex device part number from the patient's (b)(6) 2018 procedure. The implant was an ar-8911ds, lot 19419, mini tightrope repair. Additional information obtained 1/16/2020: patient has reported that she has spoken with the surgeon who informed her that he accessed a different area and therefore the original tightrope suture is still in her foot and the original tightrope buttons remain in her bone. Nothing was explanted and the surgeon told the patient that he could remove them later on if needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01646 |
| MDR Report Key | 9667429 |
| Report Source | CONSUMER |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-09-20 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2020-02-04 |
| 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 | MINI TIGHTROPE REPAIR |
| Generic Name | WASHER, BOLT NUT |
| Product Code | HTN |
| Date Received | 2020-02-04 |
| Model Number | MINI TIGHTROPE REPAIR |
| Catalog Number | AR-8911DS |
| Lot Number | 19419 |
| 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 | 2020-02-04 |