MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-20 for MIDAS REX? LEGEND FOOTED ATTACHMENT AF02 manufactured by Mdt Powered Surgical Solutions.
[188140950]
Report confirmed. Evaluation determined that a portion of the foot of the attachment was bent, perforated and missing. It was also noted that the bearings were corroded, o-rings were worn, the color band and and laser markings were faded. Previous investigation performed under pr#(b)(4) determined that the likely causes are debris in the collet and improper insertion of the tool. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625507-2020-00024 |
| MDR Report Key | 9734104 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2012-10-29 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 4620 NORTH BEACH STREET |
| Manufacturer City | FT. WORTH TX 761373291 |
| Manufacturer Country | US |
| Manufacturer Postal | 761373291 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Street | 4620 N BEACH ST |
| Manufacturer City | FORT WORTH TX 76137 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 76137 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDAS REX? LEGEND FOOTED ATTACHMENT |
| Generic Name | MOTOR, DRILL, PNEUMATIC |
| Product Code | HBB |
| Date Received | 2020-02-20 |
| Returned To Mfg | 2020-02-03 |
| Model Number | AF02 |
| Catalog Number | AF02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT POWERED SURGICAL SOLUTIONS |
| Manufacturer Address | 4620 N BEACH ST FORT WORTH TX 76137 US 76137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-20 |