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

Model Number	72201186
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an arthroscopy, the arthropiece clamp was damaged at the time of passing the points of the second suturefix ultra 1.9mm anchor.The procedure was completed with a non-significant delay using a back-up device.The tip of the clamp remained inside the patient and could not be removed.Patient condition is stable.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional 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 no 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.This case reports the breakage of the arthropierce clamp, per case details the tip of the clamp remained inside the patient and could not be removed.The arthropierce clamp is made of 17-4 ph stainless steel rc 40-48.The clamp is an externally communicating device, it is neither manufactured nor intended for implantation.It is also not approved for long term internal tissue exposure and long-term implantation data is not available.The patient impact beyond the reported device breakage and retained foreign body could not be definitively determined.Mico-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.There was no way to determine if the device contributed to 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 INSTRUMENT CURVED 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: 14283742
• Report Number: 1219602-2022-00633
• Device Sequence Number: 12314489
• Product Code: NBH
• UDI-Device Identifier: 03596010605610
• UDI-Public: 03596010605610
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 07/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: 72201186
• Device Catalogue Number: 72201186
• Device Lot Number: 50581680
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 62 KG