MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL TRAY TRIAL +0; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HUMERAL TRAY TRIAL +0
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that during trialing the tray during an implant procedure, the washer came out of the tray trial and the screw came loose.All parts were found.The patient was last known to be in stable condition following the event.The screw and tray are being returned.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: d9, h3, h6, h11.No device was returned for evaluation; the reported event was confirmed in part by review of photographs of the device.The review identified the tray trial screw disassembled from the ergo humeral tray trial assembly.Based on the images provided, the reported disassembly of the internal retaining ring cannot be confirmed; however, the disassembly of the screw can be confirmed.A review of complaint history determined that no further action is required as no trends were identified.A review of manufacturing data was performed, and no discrepancies were found.The disassembly issue reported may have been the result of disassembly of the tray trial screw, possibly as a result of internal retaining ring disassembly.However, the disassembly of the retaining ring could not be confirmed as the device was not returned for evaluation.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.

• Brand Name: HUMERAL TRAY TRIAL +0
• 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 ; 3523771140
• MDR Report Key: 16393286
• Report Number: 1038671-2023-00182
• Device Sequence Number: 12097389
• Product Code: LXH
• UDI-Device Identifier: 10885862580658
• UDI-Public: 10885862580658
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (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): 02/26/2026

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: HUMERAL TRAY TRIAL +0
• Device Catalogue Number: 321-14-00
• Device Lot Number: 50033544
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 02/26/2026
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female