MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for MD SERIES LONG STRAIGHT ATTACHMENT 5100015270 manufactured by Stryker Instruments-kalamazoo.
[145114578]
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 10? Events were reported for this quarter. ? Product return status: 9 devices were received. 1 device was not available for evaluation. ? Event confirmation status: 2 reported events were confirmed; the cause traced to component failure. 6 reported events were not confirmed. 1 device evaluation is still in progress. Evaluation results: 2 devices were found to be affected by internal component corrosion. 1 device was found to be affected by worn internal components. 1 device was found to be affected by lubrication breakdown. 2 devices were found to be affected by debris. 1 device was found to be affected by internal component corrosion and debris. 1 device had no device problem found. ? Additional information: 10? Devices were not labeled for single-use. 10 devices were not reprocessed and reused.
Patient Sequence No: 1, Text Type: N, H10
[145114579]
This report summarizes 10 malfunction events in which the device reportedly overheated. 9 events had no patient involvement; no patient impact. 1 event had patient involvement; no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2019-01357 |
| MDR Report Key | 8546015 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-07-08 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2019-01-01 |
| Date Added to Maude | 2019-04-24 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ZACH BAKER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MD SERIES LONG STRAIGHT ATTACHMENT |
| Generic Name | UNIT, OPERATIVE DENTAL |
| Product Code | EIA |
| Date Received | 2019-04-24 |
| Catalog Number | 5100015270 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-24 |