MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON,CL ULTRA, 20MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200147
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the surgeon felt that the condition of graft was not good compared with usual.When the graft was pulled up into prepared bone site, endobutton cl was checked outside femoral bone site and it was frayed.Then graft was pulled up for fixing.For final check of fixing, when suture was pulled up, graft was cut and came out from bone site.Therefore, endobutton cl was got back and found that part of cl damaged and cut.
Additional Manufacturer Narrative
One 72200147 20mm ultra cl endobutton was returned.The continuous loop is no longer a full loop.The fibers have been quite unwound, frayed and matted like a birds nest.There are not clean shear edges as would be if the loop had let go at the connection point.These are jagged stressed breakages as from pull force or friction rubbing against another instrument or device.This fiber is sensitive to excess handling as with pulling suture or tissue back and forth through.There is evidence of attempted repair with a cyanoacrylate surgical adhesive ¿liquid stitches¿ which compounded the damaged condition of the fibers.No root cause related to the manufacturing of this device was established.

• Brand Name: ENDOBUTTON,CL ULTRA, 20MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7547796
• Report Number: 1219602-2018-00661
• Device Sequence Number: 16179043
• Product Code: MBI
• UDI-Device Identifier: 03596010597267
• UDI-Public: (01)03596010597267(17)220815(10)50680030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 08/15/2022
• Device Model Number: 72200147
• Device Catalogue Number: 72200147
• Device Lot Number: 50680030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 05/28/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1