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	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device had vibration and worn bearings.Therefore, the reported condition that the device was making an abnormal noise was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.(b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the craniotome attachment device had vibration, and the bearings were worn.It was further determined that the device failed pretest for vibration.It was noted in the service order that the device was making an abnormal noise during an unspecified surgical procedure.It was reported that there were no delays to the surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.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: 10411894
• Report Number: 1045834-2020-01290
• Device Sequence Number: 14241922
• 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): 06/19/2020

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: 07/28/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1