MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE TBL RADEL IMPCTR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	351-17-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the radel tibal impactor the plastic piece that is attached to the impactor bent and broke off.None of the plastic piece entered the wound site or was left in the patient.Patient was last known to be in stable condition following the event.Unable to obtain photos/x-rays.No information of product available for return.No other information reported.
Additional Manufacturer Narrative
Pending evaluation.
Additional Manufacturer Narrative
The broken mobile bearing tibial radel impactor reported was likely the result of a stress riser introduced during numerous surgical uses, which led to crack initiation, propagation, and ultimate fracture of the radel surface.However, this cannot be confirmed as the device was not available for evaluation and images were not provided.Section h11: the following sections have corrected information: (h6) component code: 4722, shock absorber.

• Brand Name: VANTAGE TBL RADEL IMPCTR
• 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: 17037795
• Report Number: 1038671-2023-01194
• Device Sequence Number: 17883932
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/30/2026

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: 351-17-02
• Device Lot Number: 314753001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 07/30/2026
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/10/2023; 07/30/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown