MAUDE Adverse Event Report: CAYENNE MEDICAL APERFIX II TIBIAL SYSTEM PEEK IMPLANT; SCREW, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: cm-3008 aperfix tibial, implant 8x30mm , lot 65956908.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during surgery, the surgeon malleted the sheath in the joint space and the instrument fractured.Returned device has a fractured implant as well.All pieces were retrieved, and another implant was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual inspection shows that the sheath holder and implant are fractured.The device was returned disassembled.No other damage was noted on the inserter.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The root cause of the reported issue is attributed to use error, failure to follow instructions as complaint description states a mallet was used.Per the aperfix tibial implant instructions for use states "the use of tools that may cause excessive force during implant placement should be avoided." additionally, the ifu does not mention to use a mallet for insertion and placement.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: APERFIX II TIBIAL SYSTEM PEEK IMPLANT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer (Section G): CAYENNE MEDICAL; 16597 n 92nd street; scottsdale AZ 85260
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18226705
• Report Number: 3006108336-2023-00041
• Device Sequence Number: 6211846
• Product Code: HWC
• UDI-Device Identifier: 00887868269684
• UDI-Public: (01)00887868269684(17)280413(10)65956908
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: N/A
• Device Catalogue Number: CM-3008
• Device Lot Number: 65956908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Patient Age: 21 YR
• Patient Sex: Male