MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-02-06 for SYSTEM 5 RECIP/STERNUM SAW 4207000000 manufactured by Stryker Instruments-kalamazoo.
[5565999]
It was reported during service at manufacturer facility that a part of the handpiece chuck is broken off. 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
[12802561]
The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed. Failure analysis is in progress.
Patient Sequence No: 1, Text Type: N, H10
[16992129]
It was reported during service at manufacturer facility that a part of the handpiece chuck is broken off. 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
[17166577]
The reported event, part of chuck and yoke assembly was broken off, was confirmed. The piece that was broken off was all internal and nothing fell out of the handpiece. The chuck and yoke assembly was replaced with other suggested components. Preventative maintenance was performed and the handpiece was returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2015-00405 |
| MDR Report Key | 4492084 |
| Report Source | 07 |
| Date Received | 2015-02-06 |
| Date of Report | 2015-01-12 |
| Date of Event | 2015-01-12 |
| Date Mfgr Received | 2015-03-18 |
| Device Manufacturer Date | 2005-12-09 |
| Date Added to Maude | 2015-02-06 |
| 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 RECIP/STERNUM SAW |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-02-06 |
| Returned To Mfg | 2015-01-07 |
| Catalog Number | 4207000000 |
| Operator | OTHER |
| 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 | 2015-02-06 |