MAUDE Adverse Event Report: EXACTECH, INC. ERGO; BROACH HANDLE

Catalog Number	301-05-01
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the retroversion bar became stuck in 20 degrees left slot.Cross threaded.Could not remove and adjust to any other version during set-up.Patient was not involved.No issues with patient upon leaving the or.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
Section h10: (h3) the jammed devices reported were likely the result of plastic deformation due to cross-threading, which led to thread deformation and the inability to separate the devices.

• Brand Name: ERGO
• Common Device Name: BROACH HANDLE
• 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: 12778699
• Report Number: 1038671-2021-00599
• Device Sequence Number: 6025305
• Product Code: LXH
• UDI-Device Identifier: 10885862530479
• UDI-Public: 10885862530479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2022

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 Catalogue Number: 301-05-01
• Device Lot Number: 164119002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 02/01/2022
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown