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	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
When we were impacting the liner implant, the distal portion of the impactor chipped off and broke.Patient was last known to be in stable condition following the event.The device will be returned.
Additional Manufacturer Narrative
(h3) based on historical complaint evaluations, returned devices, and reported events, the broken offset cup impactors reported were likely the result of fatigue fracture initiated over time which led to ultimate fracture of the flexible locking tabs.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.

• 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: 12342245
• Report Number: 1038671-2021-00401
• Device Sequence Number: 3515719
• Product Code: LXH
• UDI-Device Identifier: 10885862020376
• UDI-Public: 10885862020376
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 11/22/2021

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
• Device Catalogue Number: 121-01-02
• Device Lot Number: 85742001
• 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: 07/23/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 11/22/2021
• 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 Sex: Male