MAUDE Adverse Event Report: EXACTECH, INC. HEAD PUSHER, MOD, LOWPRO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HEAD PUSHER, MOD, LOWPRO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of a stress riser introduced during impaction, which led to crack initiation, propagation, and ultimate fracture of the device.However, this cannot be confirmed as the device was not returned for evaluation.The most probable root cause associated with the reported event of "broken / non-functional" is associated with a partial or full-thickness crack in the device materials.
Event or Problem Description
As reported, during impaction, black plastic of head impactor broke into pieces while impacting final head implant.Surgeon had to open another tray for impactor.Patient was last known to be in stable condition following the event.Nurse threw away broken plastic head impactor tip.Still have handle.The device will not be returned.

• Brand Name: HEAD PUSHER, MOD, LOWPRO
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 12150680
• Report Number: 1038671-2021-00337
• Device Sequence Number: 3652458
• Product Code: LXH
• UDI-Device Identifier: 10885862256607
• UDI-Public: 10885862256607
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: HEAD PUSHER, MOD, LOWPRO
• Device Catalogue Number: 01-001-03-0001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR