MAUDE Adverse Event Report: EXACTECH, INC. OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, during impaction, surgeon used cup impactor to insert implant.When he was releasing impactor from implant by pressing the button, the button broke right off the handle.Pieces that broke off were all accounted for.Patient was last known to be in stable condition following the event.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) as determined the broken cup impactor reported in was likely the result of both inadequate material design and methods.The feature failing on the body of the handle tended to measure on the low end of the tolerance range allowable in the devices returned.This indicates that the failing feature is either dimensioned too small or toleranced inappropriately for its function, thus leading to failure.Additionally, the feature failing was not deemed critical to quality.A lack of methods to establish critical design features of button mechanisms and how to test or inspect them resulted in this dimension not being considered critical to quality.A risk assessment has been initiated to escalate this issue.

• Brand Name: OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12128996
• Report Number: 1038671-2021-00326
• Device Sequence Number: 11868370
• Product Code: LXH
• UDI-Device Identifier: 10885862520616
• UDI-Public: 10885862520616
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/09/2022

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 Model Number: OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION
• Device Catalogue Number: 181-02-00
• Device Lot Number: 400205001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Female