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

Catalog Number	QD8
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the attachment device produced 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 unknown.However, it was reported that the event occurred in 2025.All available information has been disclosed.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: correction h6: device evaluation: it was also determined that the device produced unexpected noise.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: correction: device availability: d9: the device availability date was incorrect in the initial report.The date has been updated from 2/28/2025 to 3/5/2025.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device had a worn bearing, produced heat, exhibited vibration, was loose and had cosmetic damage.It was also noted that the device had shaft scratches, nose tube was loose, set screw was loose and abnormal noise.It was further determined that the device failed pretest for visual assessment, nose tube assembly, thimble set screw, vibration and temperature.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.

• Brand Name: 8CM ANGLE 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: 21641424
• Report Number: 1045834-2025-00189
• Device Sequence Number: 15434438
• Product Code: HBC
• UDI-Device Identifier: 00845384006626
• UDI-Public: (01)00845384006626
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2025

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: QD8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 05/28/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/27/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2012
• 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