MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 4MM FBALL,M; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	M-4B-G1
Medical Device Problem Codes	Dull, Blunt (2407); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
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.Additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device failed visual assessment.The cutter was received stuck in the reported attachment and the device showed clear signs of use, wear and corrosion.It should be noted that the most probable cause for the cutter getting stuck was likely due to debris and residue preventing the lock tabs from moving into place.The cause of the medical debris and detergent residue buildup was due to improper cleaning which is user error.The ifu states the following regarding the reported issue cleaning attachments: prior to first use the equipment must be processed per high speed cleaning and sterilization instructions.At the point of use the device must be cleaned as soon as possible after use to prevent drying blood, tissue or other biological debris and contaminates on the device.Refer to the high speed cleaning and sterilization instructions for proper cleaning.Therefore, the reported condition was confirmed.A device history review was performed, and no non-conformance's were detected related to the reported condition.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the cutter device would not cut and showed signs of corrosion.It was further determined that the device failed pretest for visual assessment.It was noted in the service order that the attachment device could not disconnect the cutter device.This event did not occur during surgery.There was no patient involvement.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.

• Brand Name: 4MM FBALL,M
• 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: 14755464
• Report Number: 1045834-2022-00727
• Device Sequence Number: 14979014
• Product Code: HBC
• UDI-Device Identifier: 00845384012474
• UDI-Public: 00845384012474
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 02/06/2025
• Device Model Number: M-4B-G1
• Device Catalogue Number: M-4B-G1
• Device Lot Number: P093141969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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