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 2020-03-27 for BATTERY HANDPIECE/MODULAR FOR TRS 05.001.201 manufactured by Depuy Synthes Products Llc.
[186534897]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If additional information should become available, a supplemental medwatch report will be sent accordingly. The device serial or lot number was unknown concomitant medical devices and therapy dates: coupling device and reaming device. March 16, 2020. The manufacturing location was unknown. Device manufacture date was unknown. Udi: the device serial or lot number was unknown; therefore, udi: (b)(4). Unknown
Patient Sequence No: 1, Text Type: N, H10
[186534898]
It was reported from (b)(6) that during an open reduction internal fixation surgery for femoral shaft fracture, it was observed that the battery handpiece device and the quick coupling device spun themselves and didn't work properly during reaming. It was reported that the "afj" was used in the case of the right femur. According to the reporter, the opening reamer device was installed in the "dhs" quick coupling and the reaming occurred when the battery handpiece and the coupling device were idle. It was reported that the user switched to another (b)(4) device and the surgery was completed successfully. It was reported that there was about a 30 minute delay in the surgical procedure. There was patient involvement. There were no 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
| Report Number | 8030965-2020-02343 |
| MDR Report Key | 9888600 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-27 |
| 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. KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BATTERY HANDPIECE/MODULAR FOR TRS |
| Generic Name | MOTOR, SURGICAL INSTRUMENT, AC-POWERED |
| Product Code | GEY |
| Date Received | 2020-03-27 |
| Catalog Number | 05.001.201 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SYNTHES PRODUCTS LLC |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |