MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 12.4CM HEAVY DUTY LONG ATTCH; MOTOR, DRILL, ELECTRIC - ATTACHMENT

Catalog Number	LONG-HD
Medical Device Problem Code	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
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was generating heat.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.Udi ¿ (b)(4).
Event or Problem Description
It was reported from the (b)(6) that during service and evaluation, it was determined that the attachment device was generating heat, and the etching triangle with exclamation mark was missing (illegible etch and missing label).It was further determined that the device failed pretest for labeling assessment and temperature assessment.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: 12.4CM HEAVY DUTY LONG ATTCH
• 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: 11585678
• Report Number: 1045834-2021-00494
• Device Sequence Number: 4781298
• Product Code: HBC
• UDI-Device Identifier: 00845384003595
• UDI-Public: 845384003595
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K080802
• 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): 03/18/2021

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 Catalogue Number: LONG-HD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1