MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTURE MANIPULATOR; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7209494
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopy, when the surgeon used the suture manipulator to retrieve the anchor wires, it broke in his hand.The doctor managed to remove the pieces that fell on the patient.The procedure was performed, without any delay, using the same faulty device.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: h2: additional information on: b5.
Event or Problem Description
It was reported that, during a shoulder arthroscopy, when the surgeon used the suture manipulator to retrieve the anchor wires, it broke in his hand.When the surgeon pulled the device out, it fell on top of the patient and fell apart.The surgeon managed to remove the pieces so nothing was left inside.The procedure was performed, without any delay, using the same faulty device.No further complications were reported.
Additional Manufacturer Narrative
H11 h3, h6 the reported device was not returned to the designated complaint unit for independent evaluation.However, an analysis of the customer provided image found a suture manipulator next to a bag.The handle assembly is separated in two sections, and a spring can be seen next to the shaft.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 findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include an impact inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: SUTURE MANIPULATOR
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23402877
• Report Number: 1219602-2025-02659
• Device Sequence Number: 9872025
• Product Code: NBH
• UDI-Device Identifier: 03596010474490
• UDI-Public: 3596010474490
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 12/04/2025

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: 7209494
• Device Lot Number: 50590001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 10/20/2025; 12/03/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 10/29/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 23 YR
• Patient Sex: Male