MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT SPEED REDUCER, 60:1; MOTOR, DRILL, PNEUMATIC

Model Number	CSR60
Medical Device Problem Codes	Mechanical Jam (2983); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
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.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.H10 additional narrative: the actual device was returned for evaluation.The compact speed reducer device was evaluated and the reported condition that the device detached was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was frozen/will not move.It was further determined that the device failed pretest for speed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi ¿ (b)(4).
Event or Problem Description
It was reported from china that during pre-surgery testing it was observed that the compact speed reducer adaptor device detached.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.It was reported that an unspecified spare device was available for use, and the procedure was successfully completed.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: COMPACT SPEED REDUCER, 60:1
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• 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 33410 ; 3035526892
• MDR Report Key: 17144488
• Report Number: 1045834-2023-00915
• Device Sequence Number: 5590127
• Product Code: HBC
• UDI-Device Identifier: 00845384001782
• UDI-Public: 00845384001782
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K960630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: CSR60
• Device Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES-76059
• Patient Sequence Number: 1
• Patient Sex: Unknown