MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-16 for EVOLUTION(TM) DCF SIZING CALIPER E110-0101 manufactured by Wright Medical Technology, Inc..
[2634357]
Allegedly during sales training, the caliper would not fit with mating part.
Patient Sequence No: 1, Text Type: D, B5
[9847411]
This is a reportable malfunction. During a retrospective review of files, we determined this incident to be a reportable malfunction.
Patient Sequence No: 1, Text Type: N, H10
[19064578]
Conclusion: device was out of spec in a manner that relates to event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2012-00402 |
| MDR Report Key | 2576989 |
| Report Source | 07 |
| Date Received | 2012-05-16 |
| Date of Report | 2010-08-07 |
| Date Mfgr Received | 2012-08-10 |
| Device Manufacturer Date | 2010-07-16 |
| Date Added to Maude | 2012-09-24 |
| 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 Contact | MR DOUG SHUFELT |
| Manufacturer Street | 5677 AIRLINE ROAD |
| Manufacturer City | ARLINGTON TN 38002 |
| Manufacturer Country | US |
| Manufacturer Postal | 38002 |
| Manufacturer Phone | 9018674655 |
| Manufacturer G1 | WRIGHT MEDICAL TECHNOLOGY, INC. |
| Manufacturer Street | 5677 AIRLINE ROAD PRODUCT COMPLIANCE DEPT. |
| 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 | EVOLUTION(TM) DCF SIZING CALIPER |
| Generic Name | KNEE INSTRUMENT |
| Product Code | KTZ |
| Date Received | 2012-05-16 |
| Catalog Number | E110-0101 |
| Lot Number | 070785754 |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| 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 ROAD PRODUCT COMPLIANCE DEPT. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-16 |