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 2019-05-20 for STANDARD CRANIOTOME, BLACK MAX B-GREEN manufactured by Depuy Synthes Products Llc.
[145604735]
Udi: (b)(4). This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment. During repair, it was determined that the reported condition was confirmed. The assignable root cause was determined to be due to normal wear. If additional information should become available, a supplemental medwatch will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[145604736]
It was reported from (b)(6) that during service and evaluation, it was determined that the craniotome device neuro tip and bearings were damaged, the identification was unreadable, the ball bearing disassembled, balls were missing and the cage was not available. It was also observed that the craniotome handle was damaged (bent and abrasion), the triangle symbol was missing and the hanger, clamping and bearing failed. It was further determined that the device failed pretest for temperature, cutter insertion, lock operation and visual assessment. It was noted in the service order that the device had an unspecified malfunction. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The date of event was unknown. 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 | 1045834-2019-53641 |
| MDR Report Key | 8625333 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-20 |
| Date of Report | 2019-04-09 |
| Date Mfgr Received | 2019-05-14 |
| Device Manufacturer Date | 2010-01-19 |
| Date Added to Maude | 2019-05-20 |
| 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 | 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 | STANDARD CRANIOTOME, BLACK MAX |
| Generic Name | BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME |
| Product Code | GFF |
| Date Received | 2019-05-20 |
| Returned To Mfg | 2019-04-25 |
| Catalog Number | B-GREEN |
| 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 | 2019-05-20 |