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

Catalog Number	MEDIUM-HD-G1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H11 additional narrative: device evaluation: the actual device was returned for evaluation.During repair, it was determined that the reported condition that the device was not working during pre-testing was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device fell apart-unattached.The assignable root cause was determined to be traced to maintenance.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Event or Problem Description
It was reported that the attachment device did not work during pre-testing.During in-house engineering evaluation, it was observed that the device fell apart-unattached, color band was chipping/fading and had missing components.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.However, it was reported that the event occurred in may 2024.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 8 CM HEAVY DUTY MEDIUM ATTACHMENT
• Common Device Name: MOTOR, DRILL, ELECTRIC
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL ; 3035526892
• MDR Report Key: 19803965
• Report Number: 1045834-2024-00709
• Device Sequence Number: 8303597
• Product Code: HBC
• UDI-Device Identifier: 00845384016328
• UDI-Public: (01)00845384016328
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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-HD-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2017
• 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