MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 6.5 CM ADULT ROTATING CRANIOTOME ATTACH; MOTOR, DRILL, ELECTRIC - CRANIOTOME

Catalog Number	CRANI-A-R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi ¿ (b)(4).
Event or Problem Description
It was reported from switzerland that during service and evaluation, it was determined that the craniotome device was not functioning ¿ no rotation, the neuro tip was damaged, the bearings were damaged, and the identification was unreadable.It was noted that the rotation of the crane handle was difficult, hanger rotation, rattling ball-bearing, the triangle symbol was missing, the ball bearing was disassembled, missing balls and the cage was not available.It was further determined that the device failed pretest for temperature, cutter insertion, lock operation, and visual assessment.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 the event was not reported, however, it was reported that the event occurred in 2018.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 6.5 CM ADULT ROTATING CRANIOTOME ATTACH
• Common Device Name: MOTOR, DRILL, ELECTRIC - CRANIOTOME
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8499961
• Report Number: 1045834-2019-53370
• Device Sequence Number: 1884777
• Product Code: HBC
• UDI-Device Identifier: 00845384001744
• UDI-Public: 845384001744
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: CRANI-A-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1