MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-20 for PISTOL GRIP ASSEMBLY PG_LL manufactured by Depuy Synthes Power Tools.
[4067280]
Report received from the usa stating that the device would not engage the motor. The device was being used during surgery, but there was no patient injury. It is unknown if any user injury or medical intervention occurred. The date of the event is unknown. There was no additional information provided.
Patient Sequence No: 1, Text Type: D, B5
[11711411]
The device was received by depuy synthes power tools. The investigation is still in process. Once the investigation has been completed or if additional information is received, a supplemental report will be sent. Ref: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045834-2013-13140 |
| MDR Report Key | 3609370 |
| Report Source | 06 |
| Date Received | 2013-09-20 |
| Date of Report | 2011-01-25 |
| Date Mfgr Received | 2011-01-25 |
| Device Manufacturer Date | 2010-06-02 |
| Date Added to Maude | 2014-03-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5614943766 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | 4500 RIVERSIDE DR. |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33410 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PISTOL GRIP ASSEMBLY |
| Generic Name | RONGEUR, POWERED - PISTOL GRIP |
| Product Code | HAD |
| Date Received | 2013-09-20 |
| Returned To Mfg | 2011-01-26 |
| Catalog Number | PG_LL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DR. PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-20 |