MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-18 for UNKNOWN UNK_PRODUCT manufactured by Depuy Synthes Power Tools.
[34612658]
Additional narrative: (b)(6). The product code is unknown. Therefore, the brand name, common device name, catalog number and 510k classification are unknown. The manufacturing location was unknown. The lot/serial number device is unknown; therefore, the manufacture date is unknown. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. 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
[34612659]
It was reported from (b)(6) that after surgery, it was observed that an unknown saw blade device broke off and became stuck in the connection point of the air reciprocator device. There was no patient involvement. It was not reported if there were any injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown. 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
[39546775]
The actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the rear part of the saw blade device was stuck inside the coupling and had to be removed by disassembling the quick coupling. It was noted that the front part of the saw blade device was not available. It was further determined that the rear part of the saw blade device in the saw blade quick coupling was firmly clamped. During investigation, the part of the saw blade device was inspected and it was determined that the saw blade device did not match the synthes specification (dimensions and coating), indicating that the device was not produced by synthes. The rear part of the saw blade device stuck inside the coupling was confirmed. The assignable root cause was determined to be due to improper handling, which is user error/misuse/abuse. If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2015-17954 |
| MDR Report Key | 5310582 |
| Date Received | 2015-12-18 |
| Date of Report | 2015-12-08 |
| Date Mfgr Received | 2016-02-18 |
| Date Added to Maude | 2015-12-18 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Street | N/I |
| Manufacturer City | N/I |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | HSO |
| Date Received | 2015-12-18 |
| Returned To Mfg | 2016-01-13 |
| Catalog Number | UNK_PRODUCT |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES POWER TOOLS |
| Manufacturer Address | N/I N/I US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-18 |