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	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h10: (h3) pending evaluation.
Event or Problem Description
It was reported that the little black plastic cover on the top of the impactor snapped but it was still hanging on so in order to complete the surgery they just wrapped steri strips around it.No adverse event or delay to the surgery.No fragments, parts or pieces fell into the patient.Patient was last known to be in stable condition following the event.No other patient information/medical history provided.Unable to obtain photos/x-rays device is returning.
Additional Manufacturer Narrative
(h3) the broken mobile bearing tibial radel impactor reported was likely the result of a stress riser introduced while impacting the tibial component into the bone, which led to crack initiation, propagation, and ultimate fracture of the radel surface.Section h11: *the following sections have corrected information: (d4) lot number: 403929001.(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; gainesvile FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17563509
• Report Number: 1038671-2023-01981
• Device Sequence Number: 20499550
• Product Code: LXH
• UDI-Device Identifier: 10885862532282
• UDI-Public: 10885862532282
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 10/11/2023

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: 403929001
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 10/11/2023
• 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
• Patient Sex: Unknown