MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; STD RIGHT HUMERAL AUGMENT TRAY TRIAL

Model Number	321-00-12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(device evaluated by mfr) pending evaluation.The equinoxe humeral augmented tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present.The instrument is reusable.This product was recently approved for use in the us and 15 kits were shipped as part of a pilot launch under a limited release.Once notified of the complaint, exactech performed a risk assessment.While the overall risk of patient harm related to this issue is determined to be very low, exactech intends to halt the pilot launch and recall all equinoxe hat trails until a root cause for the failure can be established and corrective actions implemented.This 5-day report is being submitted per the requirements of 21 cfr, part 803.10(c)(2)(i).No information provided in the following section(s): age or date of birth, weight, ethnicity, implant date, device available for evaluation, date rec¿d by manufacture, device manufacture date, recall (if recall number is given), correction/removal number.
Event or Problem Description
As reported, during the procedure, the +0 lateralized tray threaded onto the fracture stem during trailing.During removal, the retaining ring inside the trial popped off and fell into the patient wound site.The retaining ring was found and removed from the patient wound site, but the surgeon could not re-thread the trail without the retaining ring.The surgeon then trailed +5 lateralized trial and when trying to thread trial onto stem the retaining ring again popped off and would not thread onto trial.The surgeon decided to stop using the hat system and used fracture stem instead.All parts were retrieved from the patient wound site and were accounted for.There was a 5-15 minute delay and there were no adverse event resulting form the delay.Patient was last known to be in stable condition following the event.Device are returning for evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the disassembly issue reported was likely the result of the retaining ring not being adequately designed to be retained in the groove of the humeral augmented tray trial body when forced is applied to the ring vie contact with the hat trail screw.

• Brand Name: EQUINOXE
• Common Device Name: STD RIGHT HUMERAL AUGMENT TRAY TRIAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11828850
• Report Number: 1038671-2021-00236
• Device Sequence Number: 19763312
• Product Code: LXH
• UDI-Device Identifier: 10885862541260
• UDI-Public: 10885862541260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191561
• 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): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 321-00-12
• Device Catalogue Number: 321-00-12
• Device Lot Number: 279244004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/14/2021
• 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: Required Intervention