MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAST-FIX 360 KPSC AND SLOTTED CANNULA; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72202674
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a meniscus repair using the fast-fix 360, when the cut of the suture has to be done, the cutter didn¿t cut.Both ts were removed and a backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One ed72202674 fast-fix 360 kpsc- knot pusher slotted cannula set used for treatment, was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.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, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity that are unrelated to manufacture include: inadvertent twisting triggering deployment ring during removal from packaging.Use inconsistent with instruction for use recommendations.Slack vs.Taught suture during cutting.Inadvertent twisting or bending of the product.Difficulty with reaching the desired tissue location.Entanglement with other instruments or devices.Product met specifications upon release to distribution.Complaint history review found no other report for this lot.

• Brand Name: FAST-FIX 360 KPSC AND SLOTTED CANNULA
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8679126
• Report Number: 1219602-2019-00660
• Device Sequence Number: 14006178
• Product Code: NBH
• UDI-Device Identifier: 00885554023169
• UDI-Public: 00885554023169
• Combination Product (Y/N): N
• Initial Reporter Country: MK
• 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): 07/11/2019

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: 72202674
• Device Lot Number: 507565508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1