MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL STEM INSERTER

Catalog Number	301-09-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during inspection of ergo pilot trays before sterilization, we discovered that the black impactor tip was broken.This did not happen during surgery, did not affect a patient.It was found in cpd after surgical use.Device to return for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the broken instrument reported was likely the result of repeat cleaning and sterilization cycles and exposure to impaction forces which likely led to crack initiation, propagation, and ultimate fracture of the stem inserter sphere.However, this cannot be confirmed for the stem inserter that was returned without the sphere, knob, and threads subcomponents.

• Brand Name: EQUINOXE
• Common Device Name: HUMERAL STEM INSERTER
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11811578
• Report Number: 1038671-2021-00226
• Device Sequence Number: 3767060
• Product Code: LXH
• UDI-Device Identifier: 10885862557681
• UDI-Public: 10885862557681
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2021

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 Catalogue Number: 301-09-10
• Device Lot Number: 146039001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention