MAUDE Adverse Event Report: EXACTECH, INC. HEAD PUSHER, MOD, LOWPRO; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a tha revision of 71 y/o male patient for a head liner exchange case, the surgeon when to use the femoral head impactor to impact the real femoral head implant onto the neck of the femoral stem.When using a standard orthopedic mallet he hit the head impactor tool twice before it cracked in half and broke.The head impactor broke in half and fell into the wound.The surgeon removed all pieces.Surgeon had to use different item to impact the head.Patient was last known to be in stable condition following the event.Image received.Sales rep was unable to obtain x-rays.The device is not available for evaluation as it was thrown away on accident during clean up.Customer needs item replaced for cases next week.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
(h3) the broken device reported was likely the result of stress risers introduced during impaction which led to crack initiation, propagation, and ultimate fracture of the devices.However, this cannot be confirmed as the broken impactor tip was not returned for evaluation.The most probable root cause associated with the reported event of ¿broken ¿ retrieved from patient¿ is associated with a partial or full-thickness crack in the device materials.
Additional Manufacturer Narrative
The broken device reported was likely the result of stress risers introduced during impaction which led to crack initiation, propagation, and ultimate fracture of the devices.However, this cannot be confirmed as the broken impactor tip was not returned for evaluation.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: HEAD PUSHER, MOD, LOWPRO
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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 ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 17202656
• Report Number: 1038671-2023-01462
• Device Sequence Number: 6695261
• Product Code: JDI
• UDI-Device Identifier: 10885862256607
• UDI-Public: 10885862256607
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K032964
• 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,Followup
• Report Date (Section B): 01/21/2025

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 Model Number: N/A
• Device Catalogue Number: 01-001-03-0001
• Device Lot Number: 70713001
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 10/03/2023; 01/17/2025
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 10/31/2023; 01/21/2025
• 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 Age: 71 YR
• Patient Sex: Male