MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CUFF STITCH 180 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC

Catalog Number	7209160
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4.
Event or Problem Description
It was reported that during a shoulder arthroscopy the cuff stitch 180 broke between the soft tissue when attempting to pierce the tissue.Piece were removed.The procedure was completed with the same faulty device with no surgical delay.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found the device lying on a paper, with the tip broken off the device.The provided product identification information did not match any known release of this part and thus a manufacturing record review could not be conducted.Based on the information available, 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 application of excessive inappropriate force on the device or an impact event inconsistent with normal use.Based on this investigation, the need for corrective action is not indicated.Internal complaint reference: (b)(4).H11 d4: lot number updated to unknown.

• Brand Name: CUFF STITCH 180 DEG RIGHT
• 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: 19135790
• Report Number: 1219602-2024-00830
• Device Sequence Number: 4683053
• Product Code: NBH
• UDI-Device Identifier: 03596010473127
• UDI-Public: 03596010473127
• 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
• Report Date (Section B): 08/05/2024

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: 7209160
• Device Lot Number: UNKNOWN
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 08/05/2024
• 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: 28 YR
• Patient Sex: Male