MAUDE Adverse Event Report: UNITED ORTHOPEDIC CALCAR REAMER, SMALL / CALCAR 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	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approve specifications.Additional complaint information monitoring for potential safety signals will be conducted through trending as part of the post-market surveillance.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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: CALCAR REAMER, SMALL / CALCAR REAMER LARGE
• Common Device Name: CALCAR REAMER
• Manufacturer (Section D): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• Manufacturer (Section G): UNITED ORTHOPEDIC; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• Manufacturer Contact: lois ho ; no. 57, park ave. 2; science park; hsinchu city, 30075 ; TW 30075
• MDR Report Key: 19612011
• Report Number: 9681642-2024-00024
• Device Sequence Number: 6974708
• Product Code: HTO
• UDI-Device Identifier: 04711605587570
• UDI-Public: (01)04711605587570(10)X23F141A
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/15/2024

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
• Device Model Number: 9110-3003 AND 9110-3002
• Device Lot Number: X23F089A AND X23F141A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female