MAUDE Adverse Event Report: EXACTECH, INC. RETROVERSION HNDL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	RETROVERSION HNDL
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that during a surgical procedure, when removing a trial stem using the stem extractor, the surgeon accidentally struck the retroversion rod, causing the screw thread to snap off within the stem extractor tool.No fragments, pieces or parts fell into patient wound.Patient was last known to be in stable condition following the event.The device is available for return.
Additional Manufacturer Narrative
Based on historical complaint investigations, the returned device, and the reported event, the broken retroversion handle reported was likely the result of the surgeon accidently impacting the retroversion handle while removing a trial stem, leading to ultimate failure of the retroversion handle.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that the event did not involve a death or serious injury nor would be likely to cause or contribute to a death or serious injury if the reported malfunction were to recur.As a result, this complaint event is no longer considered reportable by exactech and this report may be disregarded.

• Brand Name: RETROVERSION 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 15325152
• Report Number: 1038671-2022-00975
• Device Sequence Number: 5288035
• Product Code: LXH
• UDI-Device Identifier: 10885862079626
• UDI-Public: 10885862079626
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RETROVERSION HNDL
• Device Catalogue Number: 301-03-10
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 01/17/2023; 04/13/2026
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 02/14/2023; 04/20/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female