MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 5MM FLUTED BALL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)

Model Number	QD11-5B
Medical Device Problem Codes	Dull, Blunt (2407); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: concomitant med products: attachment device.The actual device was returned for evaluation.Quality engineering evaluated the cutter device and the reported condition that the device could not be removed from the dedicated attachment device was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the shaft of the device showed heavy corrosion and the burr head showed signs of regular wear.The assignable root cause of these conditions was determined to be traced to improper reprocessing and component failure due to wear.A review of the device history 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 shaft showed heavy corrosion and the head of the device showed signs of regular wear.It was noted that the cutter device was received inside a dedicated attachment device and was removed for a separate assessment.It was noted that the cutter device broke into two pieces when it was removed from the attachment device.It was further determined that the device failed pretest for visual assessment.It was noted in the service order that lever lock of the dedicated attachment device was defective and when received for evaluation it was observed that the cutting tool was received inside the attachment device and could not be removed.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 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 5MM 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
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6107428552
• MDR Report Key: 12845139
• Report Number: 1045834-2021-01798
• Device Sequence Number: 17231146
• Product Code: ERL
• UDI-Device Identifier: 00845384006138
• UDI-Public: 00845384006138
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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 Expiration Date: 06/30/2023
• Device Model Number: QD11-5B
• Device Catalogue Number: QD11-5B
• Device Lot Number: M213131532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown