MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION CALCER REAMER, SMALL / BROACH #4

Model Number	9110-3002 AND 9110-6004-RA
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	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The calcar planer instrument (part number 9110-3002) and broach #4 (part number 9110-6004-ra) were used during a hip surgery on (b)(6) 2024 at (b)(6) by the surgeon.The surgeon complained that the calcar planner's and broach#4 were not connecting as intended.Surgeon then used a smaller size calcar planner to connect to the broach and completed the case.Metal shaving debris did not come out of the instrument, however, when visually looking inside the calcar planner, metal pealing was observed.The surgeon closely inspected the wound to confirm there was no metal residue in the patient and the broken instrument.The instruments had already performed their function and there was no further incident.The instruments were retrieved according to complaint handling procedures for evaluation after the case completion.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.Based on 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.

• Brand Name: CALCER REAMER, SMALL / BROACH #4
• Common Device Name: REAMER
• Manufacturer (Section D): UNITED ORTHOPEDIC CORPORATION; 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: 19768582
• Report Number: 9681642-2024-00025
• Device Sequence Number: 8608700
• 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): 07/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 9110-3002 AND 9110-6004-RA
• Device Lot Number: X23F141A, T22M913A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female