MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-02 for SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE 4205000000 manufactured by Stryker Instruments-kalamazoo.
[5475759]
It was reported during set up before a procedure at user facility, the handpiece is overheating and it is running on its own once connected with the battery. The procedure was completed successfully using back-up equipment. No delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[5577438]
It was reported during set up before a procedure at user facility that the handpiece is overheating and it is running on its own once connected with the battery. The procedure was completed successfully using back-up equipment. No delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5
[12936629]
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed. Failure analysis in progress.
Patient Sequence No: 1, Text Type: N, H10
[13077761]
The reported event, handpiece is overheating and runs on its own, was confirmed. Device was repaired and returned to the customer after passing the final inspection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-00735 |
| MDR Report Key | 4561198 |
| Report Source | 06 |
| Date Received | 2015-03-02 |
| Date of Report | 2015-02-03 |
| Date of Event | 2015-02-03 |
| Date Mfgr Received | 2015-03-23 |
| Device Manufacturer Date | 2004-03-31 |
| Date Added to Maude | 2015-03-02 |
| 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 DUAL TRIGGER ROTARY HANDPIECE |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-03-02 |
| Returned To Mfg | 2015-02-05 |
| Catalog Number | 4205000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-03-02 |