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

Catalog Number	7209161
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign post code (b)(6).
Event or Problem Description
It was reported that, during an arthroscopic rotator cuff repair surgery, the tip of the cuff suture broke and got caught in the thread.It is unknown whether the broken fragments were removed or left inside of the patient.A back-up device was available to complete the procedure, with neither surgical delay nor patient injuries as consequences of the alleged malfunction.
Additional Manufacturer Narrative
The reported cuff stitch 180 degree left is intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke off during use, causing the tip to break off in the patient.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive forces applied to the device can result in failure.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: CUFF STITCH 180 DEG LEFT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8331079
• Report Number: 1219602-2019-00177
• Device Sequence Number: 16602574
• Product Code: NBH
• UDI-Device Identifier: 03596010448927
• UDI-Public: 03596010448927
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 7209161
• Device Lot Number: 50349351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR