MAUDE Adverse Event Report: EXACTECH, INC.; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HUM LNR IMPACT TIP 36MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
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 an initial implant procedure, the impactor tip broke during poly impaction.No pieces fell into the patient wound site.Pieces were all accounted for.The surgery and pt were unaffected.The patient was last known to be in stable condition following the event.The device is available for return.
Event or Problem Description
Based on historical complaint investigations and the reported event, the fractured humeral liner impactor tip reported may have been the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture.Additionally, the device may have experienced material degradation if sterilized beyond the recommended parameters listed in the reprocessing instruction which could have led to the observed failure.However, this cannot be confirmed as the device was not available for evaluation.

• Brand Name: UNK
• 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 66th ct.; gainesville FL 32653
• Manufacturer Contact: julia goldberg ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16464661
• Report Number: 1038671-2023-00316
• Device Sequence Number: 12680573
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 09/15/2026

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: HUM LNR IMPACT TIP 36MM
• Device Catalogue Number: 321-09-36
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 09/15/2026
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/18/2023; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female