MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE TRAY BROACH ADAP

Catalog Number	321-05-21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, on may 3rd a staff member from sterile processing found a wire that was protruding out of the inner rim of the preserve adapter tray trial.The sterilization department wanted to know if this was hazardous and if it had to be removed/inserted back in for cleaning.Staff ended up removing the wire for cleaning and found debris under the wire.On may 7th, it was confirmed that the wire is in fact a spring to help with keeping the inserts in place during trial reduction.However, the customer is sending the instrument back to exactech for investigation to ensure there is nothing damaged.
Additional Manufacturer Narrative
(h3) the damaged humeral tray trial reported was likely the result of either unauthorized disassembly of the spring for cleaning or improper disassembly of the humeral liner trial from the humeral tray trial, which may have caused the lock spring to deform.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 288709015 section h11: the following sections have corrected information: (h3) the reported event, and the returned device, the damaged humeral tray trial reported was likely the result of either removing the spring for cleaning or improper disassembly of the humeral liner trial from the humeral tray trial, which may have caused the lock spring to deform.(h6) type of investigation: testing of actual/suspected device, investigation findings: stress problem identified, investigation conclusions: cause not established.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE TRAY BROACH ADAP
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 11928829
• Report Number: 1038671-2021-00277
• Device Sequence Number: 14262234
• Product Code: LXH
• UDI-Device Identifier: 10885862534200
• UDI-Public: 10885862534200
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2022

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 Catalogue Number: 321-05-21
• Device Lot Number: 288709015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 10/18/2021; 01/06/2022
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 11/07/2021; 01/07/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown