MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-10 for HUNTER TENDON ROD TRX0-0000 manufactured by Wright Medical Technology, Inc..
[59734764]
The investigation is not complete. Trends will be evaluated. This report will be updated when the investigation is complete. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[59734885]
Per djerbi et al 2016, "prognostic factors in two-stage flexor tendon reconstruction: is it possible to predict surgical failure? ", one case of infection of the silicone rod in between the two operations was reported.
Patient Sequence No: 1, Text Type: D, B5
[66570320]
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined. The investigation is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2016-00117 |
| MDR Report Key | 6093863 |
| Date Received | 2016-11-10 |
| Date of Report | 2016-11-08 |
| Date Facility Aware | 2016-11-07 |
| Date Mfgr Received | 2016-11-07 |
| Date Added to Maude | 2016-11-10 |
| 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 | MEMPHIS TN 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 | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUNTER TENDON ROD |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | HXR |
| Date Received | 2016-11-10 |
| Model Number | TRX0-0000 |
| Lot Number | NI |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-10 |