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

Model Number 72203793

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/16/2020

Event Type  Injury  

Event Description

It was reported that during a shoulder arthroscopy and cuff repair procedure, the truepass needles broke inside the patient.The broken pieces could not be retrieved but the joint was washed with saline and suction.The procedure was successfully completed without significant delay using a firstpass.No complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that the device ifu 10601029 cautions that ¿careful attention should be exercised to ensure that excessive force is not placed on this device.Excessive force can result in the failure of this device.¿ the truepass needle tip and shaft is made of nitinol which is a biocompatible material however, since the needle is part of a surgical device it is not approved for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of possibly retained non-implantable foreign body fragments cannot be determined.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: TRUEPASS NEEDLE SINGLE PACK STERILE BX 5
• Type of Device: 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: 10808178
• MDR Text Key: 215263386
• Report Number: 1219602-2020-01799
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885554030433
• UDI-Public: 00885554030433
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72203793
• Device Catalogue Number: 72203793
• Device Lot Number: 2041149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 47 YR
• Patient Sex: Male