MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-08 for 1.0MM DRILL FOR 1.25MM SCREW GREY-471-25 manufactured by Depuy Synthes Power Tools.
[77226318]
(b)(4). 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
[77226319]
It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the cutter device tip was broken while the surgeon tried to open a hole. It was reported that the device was in use with the motor device and an attachment device. It was unknown if there were delays to the planned surgical procedure or if a spare device was available for use. There were no reports of injuries, medical intervention or prolonged hospitalization. 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
[110729820]
Additional narrative: the actual device was returned for evaluation. Reliability engineering evaluated the device and observed that the tip of the external device was broken. The cutter was examined and photographed using 28x magnification. Based on the photographs taken the angle indicate that there was excessive force applied. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to 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
| Report Number | 1045834-2017-11257 |
| MDR Report Key | 6623231 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-08 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2012-12-14 |
| Date Added to Maude | 2017-06-08 |
| 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 | 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 | 3 |
| Brand Name | 1.0MM DRILL FOR 1.25MM SCREW |
| Generic Name | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-06-08 |
| Returned To Mfg | 2017-06-22 |
| Catalog Number | GREY-471-25 |
| Lot Number | F506012845 |
| 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 | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-08 |