MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 4MM FLUTED BALL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)

Model Number	QD11-4B
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
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.  quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was traced to component failure due to normal wear.A device history review was performed, and no non-conformances were detected related to the reported condition.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the cutter device was damaged.It was further determined that the cutter device failed visual inspection - showing signs of use and there were broken cutting etches.It was noted in the service order that the cutter device could not be removed from the attachment device.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 become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 4MM FLUTED BALL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11852670
• Report Number: 1045834-2021-00843
• Device Sequence Number: 3223357
• Product Code: HBC
• UDI-Device Identifier: 00845384006039
• UDI-Public: 00845384006039
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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 Model Number: QD11-4B
• Device Catalogue Number: QD11-4B
• Device Lot Number: N063135690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1