MAUDE Adverse Event Report: EXACTECH, INC. OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation noted that revision reported was likely the result of crack initiation, propagation, and ultimate fracture of the lever release subcomponent due to years of repeated impaction cycles and engaging/releasing the locking feature.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 a procedure, the button on alteon clamp cup inserter broke off when inserting cup into patient.Opened new tray for cup inserter.There were no parts or pieces that fell into the patient.The (b)(6) y/o female patient was last known to be in stable condition following the event.The device will be returned.

• Brand Name: OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 11876338
• Report Number: 1038671-2021-00245
• Device Sequence Number: 16418877
• Product Code: LXH
• UDI-Device Identifier: 10885862520616
• UDI-Public: 10885862520616
• 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): 05/25/2021

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: OFFSET CUP IMPACTOR LOW PROFILE, LVR ACTION
• Device Catalogue Number: 181-02-00
• Device Lot Number: 10320707001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR