MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-24 for HUNTER PASSIVE TENDON IMPLANT PT60-0000 manufactured by Wright Medical Technology, Inc..
[53923797]
The investigation is not complete. Trends will be evaluated. This report will be updated when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[53923798]
Allegedly, the rep was contacted by facility to bill for rod. Rep billed. Once csr tried to bill we could not locate lot. After research confirmed it was expired. Issue not resolved per incident form.
Patient Sequence No: 1, Text Type: D, B5
[57630502]
This incident is considered closed. If at any time new or updated information becomes available, the incident will be re-opened and investigated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2016-00086 |
| MDR Report Key | 5900325 |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-03 |
| Date Facility Aware | 2016-08-03 |
| Date Mfgr Received | 2016-08-24 |
| Date Added to Maude | 2016-08-24 |
| 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 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 PASSIVE TENDON IMPLANT |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | HXR |
| Date Received | 2016-08-24 |
| Catalog Number | PT60-0000 |
| Lot Number | 058605727 |
| Device Availability | N |
| Device Age | DA |
| 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 ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-24 |