MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-05 for N/I manufactured by Depuy Synthes Power Tools.
[49908483]
The product code is unknown. Therefore, the brand name, common device name, catalog number and 510k classification are unknown. The lot number device is unknown; therefore, the manufacture date is unknown. The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. Reliability engineering evaluated the cutter device and observed that a broken piece of the device was found inside the locking mechanism assembly. Therefore, the reported condition was confirmed. The broken piece of the cutter device was examined using 25x magnification and rechecked on an optical comparator. It was determined that a full assessment of the device could not be performed due to the condition of the cutter upon receipt. It was determined that the piece of the cutter that broke off was below the laser marking and identification of the cutter. Therefore, the lot number was not able to be identified as the rest of the cutter was not sent in. The assignable root cause of the failure was due to excessive force during use, which was component damage caused by user error. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[49908484]
It was reported that during service and repair pre-testing, it was discovered that the cutter device could not be inserted into the attachment device. It was further determined that a piece of an unknown cutter device was found inside the attachment device. The event was not related to surgery. There was no patient involvement. There were no injuries or medical intervention associated with this event. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045834-2016-12127 |
| MDR Report Key | 5769352 |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-16 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-06-30 |
| Date Added to Maude | 2016-07-05 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RODNEY CRAIN |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 5616271080 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | 4500 RIVERSIDE DRIVE |
| 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 | 0 |
| Brand Name | N/I |
| Generic Name | N/I |
| Product Code | DZJ |
| Date Received | 2016-07-05 |
| Returned To Mfg | 2016-06-06 |
| Catalog Number | N/I |
| Lot Number | N/I |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-05 |