MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200146

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/28/2020

Event Type  Injury  

Event Description

It was reported that during cl reconstruction surgery, when the tendon traction was being performed, the loop of the endobutton and bone surface were cut and broken.The procedure was completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H2: additional information on b5 and b7.

Event Description

It was reported that during cl reconstruction surgery, when the tendon traction was being performed, the loop of the endobutton was cut and broken by the bone surface.The bone did not suffer any damage.The procedure was completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 72200146 15mm ultra continuous loop endobutton used in treatment was returned for evaluation.The product fibers were visibly disturbed indication was a difficult use.The loop was unusually tainted, tattered and frayed.Running the blue green suture through the loop had obviously disrupted the fibers.The report indicated damage caused by contact with sharp bone; subsequent removal required.The product fibers are subject to fluffing upon removal from the package.Suture may catch and disrupt the loop fibers if the endobutton loop is not carefully held aside during adjustment.Finesse and care is necessary with handling the product.The nature of the filament fiber is extremely fine and the condition as a perceived flaw.There is no detriment to safety, efficacy or design intent.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Instructions for use contains recommendations and precautionary statements for proper use of product.Risk management files contain the reported failure.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.Per clinical/mi: no relevant clinical information is provided, recommend closure.

• Brand Name: ENDOBUTTON CL ULTRA 15MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10426670
• MDR Text Key: 203539146
• Report Number: 1219602-2020-01281
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: 03596010597250
• Combination Product (y/n): N
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2022
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 50657082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 08/20/2020; 10/08/2020
• Supplement Dates FDA Received: 08/27/2020; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other