MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 8CM MEDIUM ATTACH; MOTOR, DRILL, ELECTRIC

Catalog Number	MEDIUM-G1
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition that the device was not holding the cutter devices was not confirmed.However during evaluation, it was determined that the made excessive noise, had component damage, had a foreign substance and was vibrating.The device also failed pretests for vibration assessment.The assignable root cause was traced to improper maintenance.Udi: (b)(4).
Event or Problem Description
It was reported that the motor device, while in use with the attachment device, was not holding the cutter devices.During service and evaluation, it was determined that the attachment device made excessive noise, had component damage, had a foreign substance and was vibrating.It was further determined that the device failed pretest for vibration assessment.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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any 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.

• Brand Name: 8CM MEDIUM ATTACH
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10810595
• Report Number: 1045834-2020-01900
• Device Sequence Number: 4141899
• Product Code: HBC
• UDI-Device Identifier: 00845384016311
• UDI-Public: 0845384016311
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: MEDIUM-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1