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 2020-03-25 for NAVIO HANDPIECE THUMBERSCREW PFSR100026 manufactured by Blue Belt Technologies.
[188507695]
It was reported that before the tka procedure, the thumbscrew broke when tightening with t-handle. A coband wand (tape or bandage) was used to ensure that the handpiece stayed shut during the procedure and complete the surgery without delays. No other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010266064-2020-00100 |
| MDR Report Key | 9881388 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-25 |
| 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 | MR. RICK CONFER |
| Manufacturer Street | 2828 LIBERTY AVE SUITE 100 |
| Manufacturer City | PITTSBURGH PA 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 4126833844 |
| Manufacturer G1 | BLUE BELT TECHNOLOGIES |
| Manufacturer Street | 2905 NORTHWEST BLVD STE 40 SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55441 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIO HANDPIECE THUMBERSCREW |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-17 |
| Catalog Number | PFSR100026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLUE BELT TECHNOLOGIES |
| Manufacturer Address | 2905 NORTHWEST BLVD STE 40 PLYMOUTH MN 55441 US 55441 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |