MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-20 for 3MM FLUTED MATCHSTICK, 15CM MA15-8NS manufactured by Depuy Synthes Products Llc.
[184447699]
Device was used for treatment, not diagnosis. 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. Concomitant medical products: minimal access attachment device, angled driver device. Device manufacture date: the device manufacture date is unavailable. Udi: the part number is unknown. All attempts to obtain product information were unsuccessful. Therefore, udi is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[184447700]
It was reported that the minimal access attachment device shaft was stuck in the angled driver device and did not come-off. It was reported that when the physician attempted to remove the attachment device, the tip of the? Burr head? Broke-off. 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. The exact date of the event was not reported. 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 | 1045834-2020-00530 |
| MDR Report Key | 9859868 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3MM FLUTED MATCHSTICK, 15CM |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR |
| Product Code | HBE |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-23 |
| Catalog Number | MA15-8NS |
| Lot Number | N313138768 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |