MAUDE Adverse Event Report: TRIMED INC. FUSION CUP, 10 HOLE, 18MM

Model Number	FC10
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Arthritis (1723); Rheumatoid Arthritis (1724)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) reported on (b)(6)2022 that he would like to return a fc10 marked with "do not implant" on it.It was reported that this item did not come in contact with a patient and did not cause additional harm.The item is available to be returned.Pictures are available.

• Brand Name: FUSION CUP, 10 HOLE, 18MM
• Common Device Name: FUSION CUP, 10 HOLE, 18MM
• Manufacturer (Section D): TRIMED INC.; 27533 ave hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 ave hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 ave hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 15993139
• Report Number: 2031009-2022-00006
• Device Sequence Number: 20355726
• Product Code: HRS
• UDI-Device Identifier: 00842188100734
• UDI-Public: 00842188100734
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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: FC10
• Device Catalogue Number: FC10
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Unknown