MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.4MM X 12.8MM FRTR,S; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number	S-1R-G1
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from japan that during a brain aneurysm clipping surgical procedure for a brain tumor removal in the right temporal bone valve, it was observed that the drill bit broke off while creating the first tenting hole.It was reported that the device was being used with a motor device and attachment device.It was reported that the procedure was successfully completed without surgical delay.It was not reported if a spare device was available for use.There was patient involvement reported.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.
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: d10.Concomitant med products and therapy dates: motor device and attachment device (26apr2024) e1: reporters 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).
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.H11 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and 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: udi: (b)(4) correction: d4: the unique identifier (udi) has been updated 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.D9: the date device returned to manufacturer has been updated accordingly.Investigation summary: the actual device was returned for evaluation.During repair, an evaluation was performed; and it was determined that the device had the following failures: cutter fractured and corrosion/rusting/pitting.Therefore, the reported condition that the device broke off while creating the first tenting hole was confirmed.The assignable root cause was determined to be due to improper handling.The drill bit was assessed per op: g01.02.04 rev.Ba.And relevant measurements recorded on attached dwg no.65-s-1r-g1-1 rev.C, passed all manufacturing specifications and was not the cause of the failure.The most probable root cause for the broken drill bit is lateral or side to side force by the customer, and the observed corrosion is due to improper reprocessing.As part of anspach quality process all devices are manufactured, inspected, and released to approved specifications.The ifu states the following regarding the reported issue that was observed by the user or customer: do not force the cutting burrs while performing operation.Use a gentle tapping motion or side to side motion and let the instrument do the cutting.Forceful side loading of cutting burrs may cause fracture of dissecting tool.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history review: no manufacturing record evaluation required as no manufacturer or service related issue found.

• Brand Name: 1.4MM X 12.8MM FRTR,S
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 19310732
• Report Number: 1045834-2024-00467
• Device Sequence Number: 6911152
• Product Code: HBE
• UDI-Device Identifier: 00845384012627
• UDI-Public: 00845384012627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113476
• 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,Followup

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: S-1R-G1
• Device Lot Number: U053154676
• 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: 05/06/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 06/05/2024; 07/31/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 05/26/2024; 06/06/2024; 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown