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

Model Number	OFFSET CUP IMPACTOR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
It was reported that while performing a tha surgical procedure, during final impaction for the crown cup, it looks that a tip of handle was broken.There was no impact for the installation of the cup because this happened during the final step.Parts and pieces of the device fell into the patient wound.The surgeon removed the parts/pieces from the patient.There was no surgical delay/prolongation.No other patient information/medical history reported.The device is available for return.
Additional Manufacturer Narrative
H6: based on historical complaint evaluations, the returned device, and reported event, the broken offset cup impactor reported was likely the result of fatigue fracture initiated over time which led to ultimate fracture of the flexible locking tab.

• Brand Name: OFFSET CUP IMPACTOR
• 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 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14739026
• Report Number: 1038671-2022-00693
• Device Sequence Number: 11316166
• Product Code: LXH
• UDI-Device Identifier: 10885862020376
• UDI-Public: 10885862020376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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
• Device Catalogue Number: 121-01-02
• 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: 06/09/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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 Age: 84 YR
• Patient Sex: Unknown