MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION CALCER REAMER, SMALL / CALCER REAMER LARGE

Model Number	9110-3003 AND 9110-3002
Medical Device Problem Codes	Material Disintegration (1177); Structural Problem (2506); Scratched Material (3020); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The calcar planer instrument (part number 9110-3003 and 9110-3002) used during a hip surgery on (b)(6) 2024 at the surgical institute of reading by the surgeon broke while grinding and torquing the broach trial.Metal shavings were found inside the instrument, there was no evidence of them being left in the patient's body.The surgeon completed the case using another size calcar planer, and the broken instrument was retrieved after the surgery.

• Brand Name: CALCER REAMER, SMALL / CALCER REAMER LARGE
• Common Device Name: CALCER REAMER
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; no. 57, park ave, science park; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 19347048
• Report Number: 3009760038-2024-00025
• Device Sequence Number: 11414962
• Product Code: HTO
• UDI-Device Identifier: 04711605587570
• UDI-Public: (01)04711605587570(10)X23F141A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2024
• Report Date (Section F): 05/18/2024

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
• Device Model Number: 9110-3003 AND 9110-3002
• Device Lot Number: X23F089A AND X23F141A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/19/2024
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 05/18/2024