MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENSIONER, BIOSURE SYNC; ACCESSORIES,ARTHROSCOPIC

Model Number	72202754
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tensioner was found broken when opening the instrument tray during surgery.No back up device was available.
Additional Manufacturer Narrative
One 72202754 biosure sync tensioner reported on.This is a four year old reusable device.Product was not available for evaluation.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.The complaint could not be ultimately confirmed.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, product knowledge.Influences that could compromise product performance or integrity that are unrelated to manufacture include: compliance with recommended maintenance and care for the multiple components of the product.Repeat handling during disassembly, cleaning, sterilization reassembly.Use of incompatible cleaning agents that do not meet ph requirements for the product materials.Use of force before, during or after surgical procedure.This product is disassembled, cleaned and sterilized repeatedly.Inspect the device for wear or cracking.Discard the device if any wear is observed or if the tip becomes dull.Pay careful attention to cleaning devices with challenging design features.Challenging design features can include, but are not limited to, suction levers, stopcocks, interfaces, cannulations, holes, blind holes, crevices, hinges, mating surfaces, etc.Low-sudsing, neutral 6.0¿8.0 ph, enzymatic detergents are recommended.Do not use detergents above 11.0 ph.Use deionized water for washing and rinsing unless otherwise specified.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.This product met predetermined specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: TENSIONER, BIOSURE SYNC
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7965664
• Report Number: 1219602-2018-01399
• Device Sequence Number: 13845899
• Product Code: NBH
• UDI-Device Identifier: 03596010649027
• UDI-Public: (01)03596010649027(10)50517101
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2018

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 Model Number: 72202754
• Device Catalogue Number: 72202754
• Device Lot Number: 50517101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1