MAUDE Adverse Event Report: ORTHO DEVELOPMENT; IMPACTOR

Model Number	270-5100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a total hip surgery on (b)(6) 2025, the inserter was believed to be cross threaded into the cup by the scrub tech.While impacting the cup into the acetabulum, the impactor broke leaving the impactor's threads in the cup.The surgeon deemed it was not necessary to remove the threads because they did not protrude or interfere with the liner.

• Common Device Name: 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: 22029008
• Report Number: 1722511-2025-00008
• Device Sequence Number: 8141953
• Product Code: LXH
• UDI-Device Identifier: 00822409085972
• UDI-Public: (01)00822409085972(11)210504(10)2103016
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: 270-5100
• Device Lot Number: 2103016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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 Age: 65 YR
• Patient Sex: Male