MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-10-25 for AM SURGICAL BLADE SINGLE PACK AM96-BLD1 manufactured by Wright Medical Technology, Inc..
[2288497]
Allegedly the blade separated during surgery and had to be retrieved causing a delay in surgery. Approximately 45 mins.
Patient Sequence No: 1, Text Type: D, B5
[9314214]
Investigation is not complete. Trends will be evaluated. Additional information has been requested. This report will be updated when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[10069485]
Conclusion: no conclusion can be drawn. The complaint was reviewed and analysis showed no trend. Photographic images were made. (b)(4) - evidence that product in specification when used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043534-2011-00645 |
| MDR Report Key | 2307202 |
| Report Source | 05,07 |
| Date Received | 2011-10-25 |
| Date of Report | 2011-09-16 |
| Date of Event | 2011-09-07 |
| Date Facility Aware | 2011-09-07 |
| Date Mfgr Received | 2012-01-25 |
| Device Manufacturer Date | 2011-02-18 |
| Date Added to Maude | 2011-10-25 |
| 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 | 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 | AM SURGICAL BLADE SINGLE PACK |
| Generic Name | SMALL JOINT INSTRUMENT |
| Product Code | EMF |
| Date Received | 2011-10-25 |
| Returned To Mfg | 2011-09-16 |
| Catalog Number | AM96-BLD1 |
| Lot Number | 0211306371 |
| Operator | PHYSICIAN |
| 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 | 5677 AIRLINE ROAD PRODUCT COMPLIANCE DEPT. ARLINGTON TN 38002 US 38002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-25 |