MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC COMPACT SPEED REDUCER, 60:1; DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER

Model Number CSR60

Device Problems Device Reprocessing Problem (1091); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

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.Concomitant med products and therapy dates: craniotome device, attachment device (b)(6) 2021).Reporter's phone number was not provided.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).

Event Description

This is report 3 of 3 for the same event.It was reported from (b)(6) that during an unspecified surgical procedure it was observed that an unknown black liquid substance was leaking from a craniotome device, attachment device, and compact speed reducer device.It was reported that there was no delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.It was reported that the physician cleaned out the black substance from the patient.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.Quality engineering evaluated the compact speed reducer device and the reported condition that the device was leaking a black liquid substance was not confirmed.The device was visually inspected as received and it was found that the device passed visual inspection.The device passed all inspection criteria according to the pre-repair diagnostic assessment.Since no failure was found no root cause can be defined.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device where it was used against the ifu that could not be replicated when the device was tested during technical investigation.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.

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: additional information b5: additional information was received from a user submitted report.It was reported that during a craniotomy milling bone flap operation, grey-black blood water issued when flushed to cool the device.It was considered that black-gray powder produced during high-speed operation of the device.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

• Brand Name: COMPACT SPEED REDUCER, 60:1
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES - COMPACT SPEED REDUCER
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12181581
• MDR Text Key: 262052392
• Report Number: 1045834-2021-01250
• Device Sequence Number: 1
• Product Code: HBE
• UDI-Device Identifier: 00845384001782
• UDI-Public: 00845384001782
• Combination Product (y/n): N
• PMA/PMN Number: K042783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSR60
• Device Catalogue Number: CSR60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2021
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1