MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP INSTRUMENTS; AMIS BIKINI PINCER BROACH HANDLE

Model Number	01.15.10.0690
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation performed by r&d project manager.Based on the reported events and the attached photos, a small medial calcar fracture has occurred during broaching, likely due to impingement between the amis bikini pincer broach handle and the patient’ s calcar bone.It must be highlighted that the surgeon reported he was trying to sink the broach beyond the osteotomy.This is an off-label use since, according to the surgical technique, the top of the cutting teeth should be aligned with the desired neck resection.Root cause: the event was caused by a deviation from the validated surgical technique, leading to advancement of the broach beyond the femoral osteotomy level and subsequent impingement between the broach handle and the patient¿s medial calcar, resulting in a minor calcar fracture.
Event or Problem Description
During broaching, a small medial calcar fracture occurred, likely due to impingement between the amis bikini pincer broach handle and the patient's calcar bone when attempting to advance the m-finity broach (probably size 4) beyond the osteotomy.The minor fracture required no intervention; the surgeon calcar reamed the fracture away anda collared stem was successfully implanted.According to the surgical technique, the broach should not be inserted beyond the femoral osteotomy level.

• Brand Name: HIP INSTRUMENTS
• Common Device Name: AMIS BIKINI PINCER BROACH HANDLE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23579844
• Report Number: 3005180920-2025-01065
• Device Sequence Number: 9532628
• Product Code: LXH
• UDI-Device Identifier: 07630345712776
• UDI-Public: 07630345712776
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 01.15.10.0690
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/18/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female