MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEGREE LEFT; ACCESSORIES,ARTHROSCOPIC

Model Number	7209498
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, after placing the anchor, the specialist proceeded to pass the point with the forceps artropierce left but at the time of introducing it and passing the labrum, he noticed that the tip was bent, immediately proceeded to extract it and the tip of about 2mm remained on the way into the tissue, the specialist tried to extract it but could not, therefore, decided to leave it inside arguing that there is no risk to the patient as it was not floating inside the joint.In order to pass the stitch to the labrum, the artropierce 45° right forceps were used thus completing the procedure.The patient's health was not affected.The procedure was completed with non-significant delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H10: 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 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 without the requested clinical information, the reported tip breakage could not be further assessed.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined.Micro-motion or movement cannot be predicted.There is potential risk for tissue inflammation and/or pain.No further clinical/medical assessment is warranted at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.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: ARTHROPIERCE 45 DEGREE LEFT
• 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: 15880598
• Report Number: 1219602-2022-01866
• Device Sequence Number: 5398536
• Product Code: NBH
• UDI-Device Identifier: 03596010474537
• UDI-Public: 03596010474537
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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 Model Number: 7209498
• Device Catalogue Number: 7209498
• Device Lot Number: 50967858
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 16 YR
• Patient Sex: Male