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

Catalog Number	7209160
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy, the device broke.Broken pieces were removed from patient using tweezers.No back up device was available.No delay or patient injuries were reported.
Additional Manufacturer Narrative
The reported 180 degree cuff stitch right intended for use in treatment, has been returned for evaluation.The distal tip has been broken off and was not returned for evaluation.The devices shaft is bent.Examination of the break area shows no material voids.The break area does exhibit plastic deformation.The condition of the device indicates it was subjected to excessive forces during use.Per the devices instructions for use under ¿precautions¿ ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during a shoulder arthroscopy, the device broke.Broken pieces were removed from patient using tweezers.The procedure was completed with the same device.No delay or patient injuries were reported.

• Brand Name: CUFF STITCH 180 DEG RIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9102258
• Report Number: 1219602-2019-01156
• Device Sequence Number: 3007691
• Product Code: NBH
• UDI-Device Identifier: 03596010448910
• UDI-Public: 03596010448910
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2019

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: 7209160
• Device Lot Number: 50522077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 09/21/2019; 10/30/2019
• Initial Report FDA Received Date: 09/22/2019
• Supplement Report FDA Received Date: 09/24/2019; 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR