MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-22 for SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE 4203000000 manufactured by Stryker Instruments-kalamazoo.
[5839199]
It was reported during service at manufacturer facility that device is running in wrong mode. It oscillated when forward trigger was pressed. No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[5877198]
It was reported during service at manufacturer facility that device is running in wrong mode. It oscillated when forward trigger was pressed. No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[13317144]
Through service, the service technician found that the device oscillated when it was supposed to run in the forward direction. Upon disassembly, a non-stryker asic motor controller and motor were found. The asic motor controller and motor were replaced along with other suggested components. Device was returned to the customer after passing the final inspection.
Patient Sequence No: 1, Text Type: N, H10
[13402266]
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-01865 |
| MDR Report Key | 4792360 |
| Report Source | 07 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-04-29 |
| Date of Event | 2015-04-29 |
| Date Mfgr Received | 2015-06-05 |
| Device Manufacturer Date | 2002-10-20 |
| Date Added to Maude | 2015-05-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. CASEY METZGER |
| 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 | 3 |
| Brand Name | SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-05-22 |
| Returned To Mfg | 2015-04-28 |
| Catalog Number | 4203000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-05-22 |