MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC PERFORATOR DRIVER,60:1 RATIO; MOTOR, DRILL, ELECTRIC

Model Number	CSR60-G1
Medical Device Problem Codes	Device-Device Incompatibility (2919); Environmental Particulates (2930); Noise, Audible (3273); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the netherlands that during a craniotomy procedure, it was discovered that the perforator driver device produced a lot of noise, started to produce smoke and the speed reducer started to get unusually warm.It was reported that when the device was inspected the gears appeared not to work anymore and the drive shaft did not engage with the output shaft.There was a fifteen-minute delay to the surgical procedure.A spare device was used to complete the surgery.There was patient involvement reported.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 2023.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported conditions that the device produced smoke and became unusually warm was not confirmed.Therefore, an assignable root cause for the reported conditions of smoke and heat were not determined.However, during evaluation, it was determined that the device was running with low power and a clicking sound could be heard.It was further determined that it was possible to stop the spinning device by hand.It was determined that when the device was disassembled it was found that transmission shaft of the gear was broken off which led to the found failures.It was further determined that the device failed pretest for speed assessment.The assignable root cause of the failures was determined to be due to component failure from wear.Service history review: a review of the service history record indicates that the device has not been serviced for a service condition that is relevant to the current reported condition.

• Brand Name: PERFORATOR DRIVER,60:1 RATIO
• 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: 16805570
• Report Number: 1045834-2023-00602
• Device Sequence Number: 17916276
• Product Code: HBC
• UDI-Device Identifier: 00845384016434
• UDI-Public: 00845384016434
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133604
• 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
• Report Date (Section B): 07/31/2023

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-G1
• Device Catalogue Number: CSR60-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2018
• 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