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 2020-03-19 for 1.55MM X 10MM TWIST DR,S S-1510TD-G1 manufactured by Depuy Synthes Products Llc.
[184434909]
Device was used for treatment, not diagnosis. Udi: lot/serial unknown. (b)(4). Device manufacture date: the device manufacture date is unavailable concomitant medical products and therapy dates: attachment device and motor device ((b)(6) 2020) reporter's phone number was not provided. 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
[184434910]
It was reported from (b)(6) that during an unspecified surgical procedure it was observed that the cutter device broke when being used with an attachment device and motor device. It was reported there were no delays in the procedure due to the event. It was not reported if there was a spare device available for use. There was patient involvement reported. It was reported that there were no fragments of the device left in the patient? S body. It was reported that the procedure was successfully completed. There were no reports of any 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
| Report Number | 1045834-2020-00514 |
| MDR Report Key | 9855707 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-10 |
| Date Added to Maude | 2020-03-19 |
| 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 | 4500 RIVERSIDE DRIVE |
| Manufacturer City | PALM BEACH GARDENS FL 33410 |
| Manufacturer Country | US |
| Manufacturer Postal | 33410 |
| Manufacturer Phone | 6103142063 |
| 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 | 3 |
| Brand Name | 1.55MM X 10MM TWIST DR,S |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Product Code | HBE |
| Date Received | 2020-03-19 |
| Catalog Number | S-1510TD-G1 |
| 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 | 4500 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |