MAUDE Adverse Event Report: UNITED ORTHOPEDIC CORPORATION PS HOUSING PUNCH

Model Number	9304-4102
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	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.The compained instrument has already reached the product lifetime defined in the united quality manual, and the instrument has been discarded by the hospital already, the subsequent analysis cannot be carried out.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.
Event or Problem Description
The surgeon was malleting the ps housing punch instrument (pn: 9304-4102) into the dedicated slot as intended by surgical technique.During the final hit of the mallet, the ps housing component broke into multiple pieces.It occurred at the end of the surgery after the bone was already removed, so a backup instrument was not required.All staff carefully removed the broken pieces from the surgical field, confirming none fell into the surgical site.Agent on site during the surgery was interviewed and confirmed that the instrument was used according to the standard procedure.The broken ps housing punch has been discarded by the hospital inadvertently resulting in no further analysis or inspection of the affected instrument.

• Brand Name: PS HOUSING PUNCH
• Common Device Name: PS HOUSING PUNCH
• 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: 19768591
• Report Number: 9681642-2024-00027
• Device Sequence Number: 15634679
• Product Code: HWP
• UDI-Device Identifier: 04719872175537
• UDI-Public: (01)04719872175537(10)T16L428A1
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: 9304-4102
• Device Lot Number: T16L428A1
• 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: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female