MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC STANDARD CRANIOTOME, BLACK MAX; BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME

Catalog Number B-GREEN

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Concomitant products: handpiece device, craniotome device, attachment devices, compact speed reducer device.(b)(6).Reporter's phone number was not provided.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

This is report 6 of 8 for the same event.It was reported from (b)(6) that the motor device was generating heat and leaking oil while in use with a compact speed reducer device, two craniotome devices, and four attachment devices.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were 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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The date returned to manufacturer was documented as (b)(4) 2018 on the initial report.This date has been updated to (b)(4) 2018.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the temperature of the craniotome device was above specification.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use over time.A review of the device history was performed and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: correction: it was reported in the initial report that the date returned to manufacturer was (b)(4) 2018.It was inadvertently reported in the supplemental report that the date returned to manufacturer had been changed to (b)(4) 2018.Please note that the correct date returned to manufacturer is (b)(4) 2018, as was originally reported on the initial medwatch report.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: STANDARD CRANIOTOME, BLACK MAX
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7890172
• MDR Text Key: 120756474
• Report Number: 1045834-2018-51715
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 845384000587
• UDI-Public: (01)845384000587(11)081217
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K974025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-GREEN
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/19/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 01/30/2019
• Supplement Dates FDA Received: 11/20/2018; 01/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1