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

Catalog Number B-GREEN

Device Problems Overheating of Device (1437); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4) - the device manufacture date is currently unavailable.Device manufacture date: the device manufacture date is unavailable 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 reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by (b)(6) that during service and evaluation, it was determined that the neuro tip and bearings of the craniotome device were damaged.It was determined that the device identification was unreadable, and the triangle symbol was missing.It was further determined that the hanger failed, the crane hanger (bent and abrasion) was damaged, and the ball bearings were worn.It was further determined that the device failed pretest for temperature, preload, and visual assessment.It was noted in the service order that the device had an undetermined malfunction while being used with the motor device, compact speed reducer device and attachment devices.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch 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: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 8392674
• MDR Text Key: 138212938
• Report Number: 1045834-2019-53012
• Device Sequence Number: 1
• Product Code: GFF
• UDI-Device Identifier: 00845384000587
• UDI-Public: 845384000587
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B-GREEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Date Manufacturer Received: 02/25/2019
• 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