MAUDE Adverse Event Report: EXACTECH, INC. HUM LNR IMPACT TIP 42M; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	321-07-42
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that this surgeon firstly used 38mm impactor tip on 38 humeral liner but cracked after first hit; utilized second 42mm impactor tip, after a couple of hits impactor tip was broken off.No parts or pieces fell into the patient.Patient was last known to be in stable condition following the event.Devices are returning.
Additional Manufacturer Narrative
(h3) based on historical complaint investigations, the image provided, and the reported event, the fractured humeral liner impactor tip reported was likely 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.The most probable root cause for the reported event of "broken/non-functional" is associated with a partial or full-thickness crack in the device materials.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: g: reporting contact name and email.H3: based on historical complaint investigations, the image provided, and the reported event, the fractured humeral liner impactor tip reported was likely 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.H6: medical device problem code, investigation conclusion.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h1, h6.Mdr section codes updated/corrected: g.Based on historical complaint investigations, the image provided, and the reported event, the fractured humeral liner impactor tip reported was likely 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.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: HUM LNR IMPACT TIP 42M
• 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: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18236751
• Report Number: 1038671-2023-02887
• Device Sequence Number: 6983299
• Product Code: LXH
• UDI-Device Identifier: 10885862087188
• UDI-Public: 10885862087188
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/08/2025

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: 321-07-42
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 05/03/2024; 04/15/2025; 05/08/2025
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 05/08/2024; 05/07/2025; 05/08/2025
• 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