MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CUFF STITCH 70 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC

Model Number	7209157
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery the stitch of the cuff stitch cracked.Procedure was completed with a competitor device, it is unknown if there was a delay.No further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 7209157 cuff stitch 70 deg right, retuned for evaluation.The information provided states: ¿during surgery the stitch of the cuff stitch cracked¿.This is a one-year-old device.Visual assessment confirms breakage.70 degree tip has been broken off.An exact root cause cannot be determined with confidence without the pertinent clinical details; however, factors that could have contributed to the reported event include improper cleaning of device or improper use of device.The instruction for use (1060355) states: ¿pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc¿.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.Product met specifications upon rele.

• Brand Name: CUFF STITCH 70 DEG RIGHT
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10497083
• Report Number: 1219602-2020-01359
• Device Sequence Number: 19513194
• Product Code: NBH
• UDI-Device Identifier: 03596010448880
• UDI-Public: 03596010448880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7209157
• Device Catalogue Number: 7209157
• Device Lot Number: 50823213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 08/16/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention