MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-29 for UNKNOWN BURRS & DRILLS UNK-BURRS-&-DRILLS manufactured by Depuy Synthes Products Llc.
[188387485]
Concomitant medical devices and therapy dates, motor device, (b)(6) 2020. The device serial or lot number was unknown. Udi: the part number and gtin are unknown. Catalog number, serial number and lot number are unknown. Brand name was unknown. Pma/510k: 510(k) number was unknown. Device manufacture date was unknown. This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. Quality engineering evaluated the device and it was determined that the reported condition was confirmed. It was further reported that the a full assessment of the device could not be performed due to the condition of the cutter that was received. The piece of the cutter was broken off below the laser marking and the identification of the cutter was unable to be identified and the rest of the cutter was not sent in. The assignable root cause was determined to be due to exposure to organic debris and materials which led to corrosion from improper maintenance. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[188387486]
It was reported that the motor device would not load the cutter device. During in-house engineering evaluation, it was determined that a piece of broken cutter was found inside of the motor. It was further reported that the device had excessive corrosion, and medical debris in the locking mechanism assembly which prevented the lock tabs from releasing the cutter. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of this event was unknown but was noted to have occurred in 2020. 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 | 1045834-2020-00150 |
| MDR Report Key | 9643043 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-13 |
| Date Added to Maude | 2020-01-29 |
| 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 | BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CUTTING BURR |
| Product Code | GFF |
| Date Received | 2020-01-29 |
| Returned To Mfg | 2019-03-14 |
| Catalog Number | UNK-BURRS-&-DRILLS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-01-29 |