MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203793
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an arthroscopy, when passing the true pass needle clamp, the doctor noticed that the tip of the device was broken inside the packaging.The procedure was finished with a smith and nephew back up device.There was a surgical delay of less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation.However an image evaluation was performed and found the device identification information and the tip is broken.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since the device was not returned for evaluation.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: TRUEPASS NEEDLE,SINGLE PACK,STERILE BX 5
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18711971
• Report Number: 1219602-2024-00281
• Device Sequence Number: 20847861
• Product Code: NBH
• UDI-Device Identifier: 00885554030433
• UDI-Public: 00885554030433
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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 Catalogue Number: 72203793
• Device Lot Number: 2115718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/16/2024
• Date Device Manufactured: 03/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 80 KG