MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for 8CM ANGLE ATTACHMENT QD8 manufactured by Depuy Synthes Products Llc.
[127563844]
Device was used for treatment, not diagnosis. Concomitant med products: compact speed reducer device, attachment devices, craniotome device. The actual device has been returned and is currently pending evaluation. Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.
Patient Sequence No: 1, Text Type: N, H10
[127563845]
This is report 2 of 6 for the same event. It was reported from (b)(6) that it was difficult connecting the compact speed reducer device, three attachment devices, and two craniotome devices to the motor and the devices were generating heat. It was not reported if the event occurred during a surgical procedure. It was not reported if there was a delay to a planned procedure. It was not reported if there was a spare device available for use. There was no patient involvement reported. 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 will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
[133358472]
The initial report stated the device was returned for evaluation. However, 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
[133866494]
Additional narrative: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the bearings of the device were worn. Therefore, the reported condition was confirmed. The assignable root cause was determined to be due to wear from normal use over time. A review of the device history was performed and no non-conformances were detected related to the reported condition. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045834-2018-52161 |
| MDR Report Key | 8081063 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-10-28 |
| Date of Event | 2018-10-25 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2014-10-24 |
| Date Added to Maude | 2018-11-16 |
| 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 | MS. KATE KARBERG |
| 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 PRODUCTS LLC |
| 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 | 8CM ANGLE ATTACHMENT |
| Generic Name | MOTOR, DRILL, ELECTRIC - ATTACHMENT |
| Product Code | HBC |
| Date Received | 2018-11-16 |
| Returned To Mfg | 2018-10-29 |
| Catalog Number | QD8 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Brand Name | 8CM ANGLE ATTACHMENT |
| Generic Name | MOTOR, DRILL, ELECTRIC - ATTACHMENT |
| Product Code | HBS |
| Date Received | 2018-11-16 |
| Returned To Mfg | 2018-10-29 |
| Catalog Number | QD8 |
| Lot Number | N/A |
| 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 PRODUCTS LLC |
| Manufacturer Address | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |