MAUDE Adverse Event Report: EXACTECH, INC. KLIMO FUKUDA RETRACTOR; INSTRUMENT, SURGICAL, NON-POWERED

Model Number	KLIMO FUKUDA RETRACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from the digital and marketing communications sr.Manager, exactech, that a surgeon tagged exactech in an instagram post.A physicians assistant posted, "i snapped steel in half today".A picture of the pa holding a retractor with the t-handle broken from the retractor body was shown.No further details provided.No indication of any patient impact reported.
Additional Manufacturer Narrative
H6: the fractured retractor reported may have been the result of applying a bending moment to the retractor during surgical use, which led to crack initiation, propagation, and ultimate fracture of the device.However, this cannot be confirmed as the device was not returned for evaluation and information regarding the event was not provided.

• Brand Name: KLIMO FUKUDA RETRACTOR
• Common Device Name: INSTRUMENT, SURGICAL, NON-POWERED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14884132
• Report Number: 1038671-2022-00751
• Device Sequence Number: 6245213
• Product Code: HAO
• UDI-Device Identifier: 10885862557568
• UDI-Public: 10885862557568
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: KLIMO FUKUDA RETRACTOR
• Device Catalogue Number: 317-21-05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown