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

Model Number	321-14-00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device pending evaluation.
Event or Problem Description
It was reported that the retaining ring popped out during surgery.There was no harm to the patient.No other information provided.
Event or Problem Description
It was reported that the subcomponents were missing, not disassembled during surgery.There was no harm to the patient.No parts of pieces fell into the patient.Device is returning.
Additional Manufacturer Narrative
H3: the broken device reported may have been the result of insufficient retention of the internal retaining ring in the groove on the ergo humeral tray trial body when force was applied to the ring via contact with the retained tray trial screw, which allowed for disassembly of the retaining ring and tray trial screw.The reported missing tray trial screw may have been due to a disassembled retaining ring/screw from a prior surgical use.However, this cannot be confirmed as the device was not available for evaluation.Section h11: the following sections have corrected information: h6: component code: 938, retainer; 568, screw.B5: describe event or problem: it was reported that the subcomponents were missing, not disassembled during surgery.There was no harm to the patient.No parts of pieces fell into the patient.Device is returning.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.There was no death or serious injury reported and no indication of a significant risk to public health.Additionally, death or serious injury is not likely should this event recur on a same or similar device.Based on the information provided, the event is not reportable to fda under 21 cfr 803.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed 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 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15078649
• Report Number: 1038671-2022-00826
• Device Sequence Number: 14645718
• Product Code: LXH
• UDI-Device Identifier: 10885862580658
• UDI-Public: 10885862580658
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2026

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: 321-14-00
• Device Catalogue Number: 321-14-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 03/01/2023; 12/18/2025
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 03/21/2023; 01/05/2026
• 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
• Patient Sex: Unknown