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

Model Number	72202674
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that surgeon was doing a meniscal repair using fastfix, knot pusher did not cut the suture.No backup device was readily available.No procedural delay or patient injuries were reported.
Additional Manufacturer Narrative
Codes added.
Additional Manufacturer Narrative
One fast-fix 360 kpsc was returned for evaluation.Functional assessment of the device could not confirm the reported complaint of being dull.The device was tested using fast-fix ultrabraid suture and cut as intended.Per the device ifu "while holding the suture taut, gently slide the knot pusher/suture cutter along the suture to the knot to achieve the desired tension.Continuing to hold the suture taut, push the knot pusher/suture cutter tip against the knot to recess the knot to the meniscus, and cut the suture by sliding the trigger forward".
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• 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: 7621745
• Report Number: 1219602-2018-00771
• Device Sequence Number: 1719167
• Product Code: NBH
• UDI-Device Identifier: 00885554023169
• UDI-Public: (01)00885554023169(17)230406(10)50725391
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2018

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 Expiration Date: 06/04/2023
• Device Model Number: 72202674
• Device Catalogue Number: 72202674
• Device Lot Number: 50725391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 07/23/2018; 07/23/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 07/17/2018; 07/24/2018; 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1