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	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause of the damaged guide arms on the surgical instrument was likely due to the misalignment of the housing impactor component prior to impaction with a mallet.When the impactor was misaligned and struck with force, it caused damage to the delicate guide arms of the instrument.The patient was unaffected as a replacement guide arm from another set of the same instrument was promptly obtained, allowing the procedure to be completed successfully.
Event or Problem Description
During the preparation for the posterior stabilization (ps) notch procedure, the surgeon inadvertently misaligned the housing impactor component of the surgical instrument prior to striking it with a mallet.The guide arms of the surgical instrument were damaged during the impaction process, likely due to the misalignment.A replacement guide arm component was obtained from another set of the same surgical instrument and used to complete the procedure successfully.The patient was unaffected by the instrument issue.

• 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: 19612012
• Report Number: 9681642-2024-00022
• Device Sequence Number: 15197225
• Product Code: HWA
• UDI-Device Identifier: 04719886890457
• UDI-Public: (01)04719886890457(10)22F145
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 22F145
• 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 Age: 54 YR
• Patient Sex: Male