MAUDE Adverse Event Report: EXACTECH, INC. MODULAR IMPACTOR ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	351-10-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken instrument reported was likely the result of improper use of the device during surgical procedure, as supported by durability testing and review of instrumentation design and the operative technique.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
(h3) pending evaluation.
Event or Problem Description
As reported, while using the central hole punch on the modular impactor handle, it snapped just above where it inserts into the modular handle.No parts or pieces fell into the patient wound site.There was a 5-15 minute delay to surgery.The patient did not experience any adverse events as a result.This event is not associated with a revision of exactech implants.The patient was last known to be in stable condition following the event.

• Brand Name: MODULAR IMPACTOR ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 20369512
• Report Number: 1038671-2024-03820
• Device Sequence Number: 20552466
• Product Code: LXH
• UDI-Device Identifier: 10885862318015
• UDI-Public: 10885862318015
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 351-10-13
• Device Lot Number: 144998007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown