MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for SWANSON HUNTER ROD SIZER SET 2437-0001 manufactured by Wright Medical Technology, Inc..
[49531578]
The investigation is not complete. This report will be updated when the investigation is complete. Trends will be evaluated.
Patient Sequence No: 1, Text Type: N, H10
[49531579]
Allegedly, non sterile spacer is packaged in similar fashion as the sterile implant. The warning that the spacers are not sterile is in very small print on the side of the box and can be easily missed. Both boxes are red and the same shape and size. Reported through medwatch.
Patient Sequence No: 1, Text Type: D, B5
[53302939]
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 | 1043534-2016-00064 |
| MDR Report Key | 5771222 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-07-05 |
| Date of Event | 2016-04-29 |
| Date Mfgr Received | 2016-06-06 |
| Date Added to Maude | 2016-07-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | SWANSON HUNTER ROD SIZER SET |
| Generic Name | SMALL JOINTS INSTRUMENT |
| Product Code | HXA |
| Date Received | 2016-07-05 |
| Catalog Number | 2437-0001 |
| Lot Number | 1574329 |
| 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 | 2016-07-05 |