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 2020-03-18 for UNKNOWN BURRS & DRILLS UNK-BURRS-&-DRILLS manufactured by Depuy Synthes Products Llc.
[184450326]
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. Device manufacture date: the device manufacture date is unavailable. Concomitant med products and therapy dates: attachment device ((b)(6) 2020). Reporter's complete address 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. Udi: the part number as unknown. All attempts to obtain product information were unsuccessful. Therefore, udi is unavailable.
Patient Sequence No: 1, Text Type: N, H10
[184450327]
This is report 2 of 2 for the same event. It was reported that during a demonstration of a unicondylar knee replacement surgical procedure, it was observed that the burr device did not spin freely in the long attachment due to a lack of irrigation. It was determined that this event caused both overheating of the long attachment and an e2 error (handpiece lock engaged) when the burr eventually stopped working. It was reported that after troubleshooting by exchanging the burr and re-starting the system, the problem was not solved. 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
| Report Number | 1045834-2020-00500 |
| MDR Report Key | 9848914 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-18 |
| 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 | UNKNOWN BURRS & DRILLS |
| Generic Name | MOTOR, DRILL, ELECTRIC - CUTTING BURR |
| Product Code | HBC |
| Date Received | 2020-03-18 |
| Catalog Number | UNK-BURRS-&-DRILLS |
| 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 | 2020-03-18 |