MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-14 for HUNTER TENDON ROD TR30-0000 manufactured by Wright Medical Technology, Inc..
[10959517]
Conclusion: no failure detected and product within specification. The complaint was reviewed and analysis showed no trend for item/lot. Photographic images were made of returned product. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16378403]
This investigation is not complete. Trends will be evaluated. The event code is addressed in the package insert. This report will be updated when the investigation is complete. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[16438400]
Allegedly post-op consultation on (b)(4) 2013 - no open spots. But on (b)(4) 2013, pt. Developed open wound spots on proximal and distal portions of finger. On (b)(6) 2013 pt had developed low grade sepsis. Dr removed rod.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043534-2013-01044 |
| MDR Report Key | 3170391 |
| Report Source | 01,07 |
| Date Received | 2013-06-14 |
| Date of Report | 2013-05-24 |
| Date of Event | 2013-05-03 |
| Date Facility Aware | 2013-05-06 |
| Date Mfgr Received | 2013-07-18 |
| Date Added to Maude | 2013-06-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 901867-414 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE 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, CODE:HXA |
| Product Code | HXA |
| Date Received | 2013-06-14 |
| Catalog Number | TR30-0000 |
| Lot Number | 1458122 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Address | 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-06-14 |