MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-05-16 for INFINITY 3360-0190 manufactured by Wright Medical Technology, Inc..
[75263752]
(b)(4). Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[75263753]
It was reported that the patient underwent an ankle surgery. Allegedly, the attachment screws snapped off at the thread in the tibial tray while implanting the poly insert. The broken screws were left in the tibial tray in the patient. No additional patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2017-00048 |
| MDR Report Key | 6568803 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-16 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-04-19 |
| Date Facility Aware | 2017-04-19 |
| Date Mfgr Received | 2017-04-20 |
| Date Added to Maude | 2017-05-16 |
| 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 | TIMOTHY NICKEL |
| Manufacturer Street | 1023 CHERRY ROAD |
| Manufacturer City | 38117 |
| Manufacturer Country | US |
| Manufacturer Postal | 38117 |
| Manufacturer Phone | 901451-631 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 11576 MEMPHIS ARLINGTON RD |
| Manufacturer City | 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFINITY |
| Generic Name | STARTER, BONE SCREW |
| Product Code | HWD |
| Date Received | 2017-05-16 |
| Model Number | 3360-0190 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-16 |