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

Model Number	QD8-5B
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Concomitant med products and therapy dates: attachment device device history record review: a device history review was performed and no non-conformances were identified related to the reported condition.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the initial reported condition of the device stuck in the attachment device and not able to be removed was not confirmed.Therefore, an assignable root cause was not determined.However, the reported conditions of the damaged cutter identified during service and evaluation were confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the cutter device was received stuck inside the attachment device but could be easily released during the assessment.It was found that the device failed the visual inspection.It was further observed that the device showed regular signs of normal wear and the cutting edges were damaged.It was noted in the service order that the cutter device was stuck in the attachment.It was reported that there were no delays in surgery.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 unknown.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
• MDR Report Key: 12175629
• Report Number: 1045834-2021-01234
• Device Sequence Number: 911367
• Product Code: ERL
• UDI-Device Identifier: 00845384006954
• UDI-Public: 00845384006954
• 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): 06/09/2021

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: QD8-5B
• Device Catalogue Number: QD8-5B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1