MAUDE Adverse Event Report: EXACTECH, INC. MODULAR IMPACTOR HANDLE

Model Number	MODULAR IMPACTOR HANDLE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during impaction, the ball bearing is missing and will no longer hold impactor tips.There were no fragments or pieces that fell into the patient.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.Sales rep was unable to obtain photos/x-rays.The device will be return.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections d4, g1, g3, g6, h2, h3 and h6 have been updated accordingly.(h3) per manufacturer internal investigation findings, the pin of the ergo impactor handle, that retains the ball and spring mechanism, became dislodged due to a failed weld holding in the retaining pin.The investigation showed the weld failed due to an insufficient weld call out on the engineering prints which lead to confusion between exactech and the manufacturing.Additionally, the manufacturer's process contributed to the weld failure.The manufacturer removed the filler material of the weld during post-processing/finishing of the device via a manual process.Section d10: device available for evaluation.
Additional Manufacturer Narrative
*the following sections have corrected information: h6 - type of investigation, investigation findings, investigation conclusion h3 - the primary root cause of the ball detent feature remains as ¿material¿ as identified in a capa revisions 2 and 3.Specifically, the previous revisions of the engineering drawings for the ergo and gps shoulder impactor handles referenced dimensions for the internal depth of the bore as well as a spherical radius to create the smaller diameter end opening for retention of the detent ball.Use of internal bore dimensions required an inspection method that may have contributed to damage and did not provide a method for dimensional inspection after assembly that may have resulted in non-conforming product being released to the field.However, as there have now been two failures of devices with the updated design specifications, the root cause statement for the ball detent failures in the capa is being updated to also include to document these complaints and note that the failure to fully inspect the feature leading to additional complaints.The design does not identify the ball protrusion after assembly as a critical feature and therefore, does not require inspection.Prior to the capa rev 3, exactech was not inspecting this feature at 100% and the supplier is currently not inspecting at all.

• Brand Name: MODULAR IMPACTOR HANDLE
• Common Device Name: IMPACTOR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: geoff gannon
• MDR Report Key: 18476705
• Report Number: 1038671-2024-00048
• Device Sequence Number: 6398464
• Product Code: HWA
• UDI-Device Identifier: 10885862557674
• UDI-Public: 10885862557674
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

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: MODULAR IMPACTOR HANDLE
• Device Catalogue Number: 321-09-05
• Device Lot Number: 405253003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 05/15/2024; 07/29/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 05/17/2024; 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown