MAUDE Adverse Event Report: UNITED ORTHOPEDIC PS HOUSING IMPACTOR

Model Number	9304-4103-RE
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907); Material Deformation (2976); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon had prepared the femoral posterior stabilized (ps) notch, which is a specific area on the femur bone where the ps component of a total knee replacement is positioned.During the procedure, the surgeon removed the ps impactor, and it was noted that the instrument assembly had become damaged.This type of damage to a surgical instrument is not uncommon and can occur due to the forces and stresses involved in the bone preparation process.Despite the damage to the instrument, the surgeon was able to complete the surgery without any delays or complications.This was possible because the ps notch had already been successfully prepared prior to the instrument damage.The damaged instrument had already served its purpose, and the surgeon was able to proceed with the remainder of the surgical steps.The surgery was completed without any issues or delays, as the instrument had already performed its intended function of preparing the ps notch prior to the damage occurring.
Additional Manufacturer Narrative
The damaged ps impactor instrument is likely due to the high forces and stresses involved in the bone preparation process during total knee replacement surgery.This type of instrument damage is not uncommon, as the surgeon must apply significant force to properly prepare the femoral posterior stabilized (ps) notch where the ps component will be positioned.Despite the damage, the surgeon was able to complete the surgery without any delays or complications because the ps notch had already been successfully prepared prior to the instrument damage.The damaged instrument had already served its purpose, allowing the surgeon to proceed with the remainder of the surgical steps as planned.

• Brand Name: PS HOUSING IMPACTOR
• Common Device Name: PS HOUSING IMPACTOR
• 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: 19612013
• Report Number: 9681642-2024-00023
• Device Sequence Number: 15197226
• Product Code: HWA
• UDI-Device Identifier: 04719886890457
• UDI-Public: (01)04719886890457(10)22F146
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/14/2024

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: 9304-4103-RE
• Device Lot Number: 22F146
• 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: Unknown