MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUM HD IMPCTR TIP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	311-07-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
It was reported that the device fractured upon impaction of the humeral head.No parts or pieces fell into the patient wound site.There was no surgical delay/prolongation.Patient was last known to be in stable condition following the event.No patient information/medical history available.Device is returning.
Additional Manufacturer Narrative
Section h10: (h3) based on historical complaint investigations, the returned device, and reported event, the broken impactor tip reported was likely the result of crack initiation, propagation, and ultimate fracture of the radel impaction surface related to numerous surgical uses and subsequent sterilization cycles.

• Brand Name: EQUINOXE HUM HD IMPCTR TIP
• 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: 14859960
• Report Number: 1038671-2022-00746
• Device Sequence Number: 12153338
• Product Code: LXH
• UDI-Device Identifier: 10885862084330
• UDI-Public: 10885862084330
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 311-07-07
• Device Catalogue Number: 311-07-07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 12/28/2022
• 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