MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for SWANSON FLEXIBLE HINGE TOE WITH GROMMETS G426-0002 manufactured by Wright Medical Technology, Inc..
[45756278]
The investigation is not complete. When the investigation is complete, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[45756279]
It was reported that there were inadequate labeling on implant indicating short stem or regular. On the short stem implant there is only a letter "s" next to the size number on the regular stem there is only a size number. This causes confusion to staff. There should be clearer labeling stating short stem or regular. Add'l info rec'd 4/22/2016: loan set ordered was short stem. Company set regular. One the box there is only a letter "s" to distinguish. "in my opinion, it's not good enough. Short or regular should be written. " patient was transferred to theatre recovery until a new implant was sent by courier. Waiting time 2. 5 hours. This implant error was discovered during surgery although implants were checked prior to the case. There is no suitable sizes (ie. Short/regular stem) clearly written.
Patient Sequence No: 1, Text Type: D, B5
[48336948]
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 | 1043534-2016-00032 |
| MDR Report Key | 5673935 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-20 |
| Date of Event | 2016-04-08 |
| Date Mfgr Received | 2016-06-28 |
| Date Added to Maude | 2016-05-23 |
| 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 | 901290-566 |
| 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 FLEXIBLE HINGE TOE WITH GROMMETS |
| Generic Name | SMALL JOINT COMPONENT |
| Product Code | KWH |
| Date Received | 2016-05-23 |
| Catalog Number | G426-0002 |
| Lot Number | 1550792 |
| 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 | 1. Other | 2016-05-23 |