MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 4MM DIAMOND BALL, 15CM; DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR

Model Number	MA15-4D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Reporter¿s complete mailing address and phone number were not provided.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during a resection of a combined level 5 brain lesion or skull base surgical procedure, the cutter device was split near the junction with spherical part while starting the drilling at the endonasal approach.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2020.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.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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information received from the reporter indicated that no residue was left and nor did it cause any event in the patient.Corrected data: the date of event was reported as 1/1/20 in the initial report and has been updated to 11/18/2020.
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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no non-conformances or abnormalities identified during the manufacture of the device that may have contributed to the reported condition.It was determined that the device passed all manufacturing and test requirements at the time of manufacture.Complaint history review: a complaint history review was performed which indicated that there were no complaints found for the reported lot number.

• Brand Name: 4MM DIAMOND BALL, 15CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES - CUTTING BURR
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10942268
• Report Number: 1045834-2020-02036
• Device Sequence Number: 19512008
• Product Code: HBE
• UDI-Device Identifier: 00845384004578
• UDI-Public: 00845384004578
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2020

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 Expiration Date: 05/19/2024
• Device Model Number: MA15-4D
• Device Catalogue Number: MA15-4D
• Device Lot Number: N243137882
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 12/05/2020; 02/05/2021
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/09/2020; 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1