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

Model Number	MEDIUM-HD
Medical Device Problem Codes	Device Reprocessing Problem (1091); Excessive Heating (4030)
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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the reported condition that the device had water in it was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the color band was chipping/fading, there was heat, and the bearing was worn.It was further determined that the device failed pretest for visual assessment and temperature assessment.The assignable root cause of these conditions was determined to be traced to maintenance, which user error/misuse/abuse.Udi ¿ (b)(4).
Event or Problem Description
It was reported that the attachment device had water in it.During in-house engineering evaluation it was determined that the device was generating heat.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, all available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: 8CM HEAVY DUTY MEDIUM ATTACH
• Common Device Name: MOTOR, DRILL, ELECTRIC - ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11934669
• Report Number: 1045834-2021-00879
• Device Sequence Number: 14238385
• Product Code: HBC
• UDI-Device Identifier: 00845384004905
• UDI-Public: 00845384004905
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

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: MEDIUM-HD
• Device Catalogue Number: MEDIUM-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1