MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-07-09 for LOANER SYS5 ROT DUAL TRIGGER 4205000000L manufactured by Stryker Instruments-kalamazoo.
[6829792]
It was reported during service at manufacturer facility that the handpiece runs on its own without activation. There was 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
[14251742]
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
[22884044]
The device is a loaner handpiece, it was repaired and placed back into stryker stock.
Patient Sequence No: 1, Text Type: N, H10
[22884045]
It was reported during service at manufacturer facility that the handpiece runs on its own without activation. There was 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
| Report Number | 0001811755-2015-02475 |
| MDR Report Key | 4902348 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-07-09 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-06-11 |
| Date Mfgr Received | 2015-08-05 |
| Device Manufacturer Date | 2002-07-30 |
| Date Added to Maude | 2015-07-09 |
| 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. 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 | LOANER SYS5 ROT DUAL TRIGGER |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2015-07-09 |
| Returned To Mfg | 2015-03-17 |
| Catalog Number | 4205000000L |
| 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 | 2015-07-09 |