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 2017-11-21 for HUNTER TR500000 manufactured by Wright Medical Technology, Inc..
[93199823]
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
[93199824]
It was reported that the patient underwent a surgical procedure with a hunter tendon rod being implanted. The surgeon took x-rays 9 days post-op and the rod was intact and where it should be. Allegedly, 3 months post-op the surgeon again took x-rays in preparation for the second phase of the surgery. The surgeon noticed the rod had broken with approximately 1 cm still attached distally and the other portion of the rod had migrated 2 cm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2017-00112 |
| MDR Report Key | 7048777 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-21 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-10-26 |
| Date Facility Aware | 2017-10-26 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2017-01-01 |
| Date Added to Maude | 2017-11-21 |
| 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 | 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 | HUNTER |
| Generic Name | SPATULA, ORTHOPEDIC |
| Product Code | HXR |
| Date Received | 2017-11-21 |
| Model Number | TR500000 |
| Lot Number | 1593246 |
| 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 | 2017-11-21 |