MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC 1.85MM X 16 MM FRTR,CRNA; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	A-CRN-G1
Medical Device Problem Codes	Fracture (1260); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cranitome device cutter had seized.During in-house engineering evaluation, it was determined that the device cutter had fractured into two pieces, it was difficult to remove the cutter device and was corroded.The device also failed pretest for visual assessment.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The date of event was unknown.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: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that device cutter was fractured, had broken into two pieces and was corroded which caused the cutter to be stuck in the attachment device making the lot number unreadable.The cutter most likely fractured while the user tried to remove it from the attachment device due to corrosion.There was obvious medical deposit, soap residue and corrosion which is a sign of insufficient cleaning after the procedures.Normal cleaning is expected to reduce or remove debris.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to improper handling.The lot number was unknown.The date of manufacture was unknown.Udi: (b)(4).

• Brand Name: 1.85MM X 16 MM FRTR,CRNA
• 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: 16953331
• Report Number: 1045834-2023-00764
• Device Sequence Number: 17855103
• Product Code: HBB
• UDI-Device Identifier: 00845384012603
• UDI-Public: 00845384012603
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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: A-CRN-G1
• Device Catalogue Number: A-CRN-G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (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