MAUDE Adverse Event Report: ORTHO DEVELOPMENT; CUP IMPACTOR

Model Number	C-1665
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a total hip surgery on (b)(6) 2024, the surgeon was using an impactor to insert the cup.After impacting the cup into the acetabulum, he attempted to change the position of the cup and the impactor broke leaving the impactor's threads in the cup.The surgeon was not able to move the cup so he used a hooded liner.

• Common Device Name: CUP IMPACTOR
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 19502779
• Report Number: 1722511-2024-00007
• Device Sequence Number: 15118734
• Product Code: LXH
• UDI-Device Identifier: 00822409108053
• UDI-Public: 00822409108053
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: C-1665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown