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

Catalog Number 7209160

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

It was reported that during a rotator cuff repair, in which was necessary to create a lateral portal to use a curved forceps, a cuff stitch broke inside the patient´s joint, the piece was easily removed using a kelly clamp.Surgery continued without any delay with a back-up device.No further complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an evaluation of the customer provided images was performed and found that the tip of the cuff broke off from the device.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 application of unintended inappropriate or excessive force to the device or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.

• Brand Name: CUFF STITCH 180 DEG RIGHT
• Type of Device: 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: 18489239
• MDR Text Key: 332750032
• Report Number: 1219602-2024-00088
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010448910
• UDI-Public: 03596010448910
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 7209160
• Device Lot Number: 50437062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male