MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE MDLR BROACH HNDL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	301-03-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During set up, as the broach handle was being removed, the spring and pin from the broach attachment button came out of the instrument.No pieces or parts 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 available.Device is returning.
Additional Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.
Additional Manufacturer Narrative
Section h10: (d4) lot number: 117212018.(h3) the broken modular broach handle reported may have been the result of a combination of a fractured weld, which may have been due to forcefully removing the dowel pin for cleaning and then reassembling prior to surgery, and an indirect force pathway during impaction.However, this cannot be confirmed as multiple subcomponents were not returned for evaluation.Section h11: *the following sections have corrected information: (h6) component code: 906, pin.

• Brand Name: EQUINOXE MDLR BROACH HNDL
• 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: 14878817
• Report Number: 1038671-2022-00747
• Device Sequence Number: 12306050
• Product Code: LXH
• UDI-Device Identifier: 10885862079619
• UDI-Public: 10885862079619
• 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: Health Professional,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: 301-03-01
• Device Catalogue Number: 301-03-01
• Device Lot Number: 117212018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 06/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown