MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RATCHETING T-HANDLE

Catalog Number	301-09-30
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, while revising a hrp and backing out a body locking screw, the t-handle loosened and came apart.The surgeon switched to a straight handle.There were no pieces that fell into the patient.The device will return for evaluation.
Additional Manufacturer Narrative
(h3) the broken device reported was likely the result of the ratcheting t-handle disassembling from the screw/pin driver assembly.The cause of the disassembly could not be determined as the failure mode could not be recreated but may have been due to not fully assembling the screw/screw driver assembly or unintentionally sliding the connection mechanism during use.

• Brand Name: EQUINOXE
• Common Device Name: RATCHETING T-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 kate jacobson ; 3523771140
• MDR Report Key: 11811582
• Report Number: 1038671-2021-00227
• Device Sequence Number: 3767061
• Product Code: LXH
• UDI-Device Identifier: 10885862557575
• UDI-Public: 10885862557575
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/21/2022

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: 301-09-30
• Device Lot Number: 147795001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 04/21/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown