MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® INLINE BROACH HANDLE; HIP INSTRUMENT

Model Number	INLNBRHN
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, the tip of the broach handle that engages the broach was broken off.Not exactly sure when that happened.We only learned that it was broken off when the surgeon went to withdraw the broach from the femur.When he would strike the broach handle with the mallet it would come out of the broach, leaving the broach in the femur.We had to use a coker to pull the broach out.We did take an ex-ray of the hip and found no debris in the wound.

• Brand Name: PROFEMUR® INLINE BROACH HANDLE
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 25257841
• Report Number: 3010536692-2026-00181
• Device Sequence Number: 5495770
• Product Code: LZO
• UDI-Device Identifier: 00192629140622
• UDI-Public: 00192629140622
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: INLNBRHN
• Device Catalogue Number: INLNBRHN
• Device Lot Number: CN103906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male