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 2017-07-13 for HUNTER TR300000 manufactured by Wright Medical Technology, Inc..
[79909500]
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
[79909501]
It was reported that the patient underwent a surgical procedure. Sometime post-op the tendon rod ruptured. The patient underwent a revision surgery to remove and replace the tendon rod. No additional patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[111226656]
The tendon rod was returned for evaluation. Visual examination confirms that the device has fractured at the sutured end of the rod. Also visual examination shows that the suture had not been passed through the polyester core which indicates that the suture was not passed through the polyester tape core initially.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2017-00076 |
| MDR Report Key | 6710086 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-13 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-06-15 |
| Date Facility Aware | 2017-06-15 |
| Date Mfgr Received | 2017-06-15 |
| Device Manufacturer Date | 2017-02-01 |
| Date Added to Maude | 2017-07-13 |
| 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 | DUSTIN SMITH |
| 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 | 2017-07-13 |
| Returned To Mfg | 2017-08-10 |
| Model Number | TR300000 |
| Lot Number | 1594606 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2017-07-13 |