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	Foreign Body In Patient (2687)
Date of Event	06/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: case (b)(4).
Event or Problem Description
It was reported that, during a shoulder repair surgery, the true pass needle broke.The broken part was carefully searched, however, it could not be found.The size of the broken part was about 2mm.Since the surgeon did not find the broken part, the patient was stitched up and the procedure was completed, however, it is unknown if there was any delay.After surgery, through a cb machine fluoroscopy, it was confirmed that the cartridge for the truepass suture clamp was left inside the patient.No further complications were reported.Patient was discharged smoothly.
Additional Manufacturer Narrative
H10: h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the potential for micro-motion and/or migration, and local skin irritation/discomfort cannot be rule out.No additional plans for an attempted device removal have been provided or complications reported.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.

• 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: 17410120
• Report Number: 1219602-2023-01364
• Device Sequence Number: 5922944
• Product Code: NBH
• UDI-Device Identifier: 00885554030433
• UDI-Public: 00885554030433
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72203793
• Device Lot Number: 2085286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/11/2023
• Date Device Manufactured: 12/10/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male