MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 7.5CM ANGLE ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC)

Model Number	QD8-S
Medical Device Problem Codes	Vibration (1674); Mechanical Jam (2983); Complete Loss of Power (4015); Excessive Heating (4030)
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.The actual device was returned for evaluation.The attachment device was evaluated and the reported condition that the device was stuck, not working was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the had vibration and was generating heat.The assignable root cause of these conditions was determined to be traced to the user, which is user error.Udi ¿ (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the angle attachment device had a worn bearing, the color band was chipping/fading, there was vibration, heat, and component damage.It was further determined that the device failed pretest for visual assessment, vibration, and temperature assessment.It was noted in the service order that the device was stuck, not working.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: 7.5CM ANGLE ATTACHMENT
• 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: 12267199
• Report Number: 1045834-2021-01330
• Device Sequence Number: 4440749
• Product Code: ERL
• UDI-Device Identifier: 00845384007159
• UDI-Public: 00845384007159
• 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): 07/07/2021

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-S
• Device Catalogue Number: QD8-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1