MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 20MM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72200147
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pcl procedure, when pulling the graft, loop of the endobutton cl got ruptured.A backup device was available to complete the procedure.A delay greater than 30 minutes was reported.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 20mm endobutton ultra cl, used in treatment, has been returned for evaluation.Visual assessment of the device confirmed the reported complaint.The cl has broken where the graft would be located when the construct is assembled.The break appears more like a clean cut rather than a breakage as there is no fraying or elongation of the cl strands.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: incidental contact with a sharp object.Excessive force applied due to incorrect tunnel diameter or length.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lots, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ENDOBUTTON CL ULTRA 20MM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9581000
• Report Number: 1219602-2020-00078
• Device Sequence Number: 667549
• Product Code: GAT
• UDI-Device Identifier: 03596010597267
• UDI-Public: 03596010597267
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2020

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: 04/01/2024
• Device Model Number: 72200147
• Device Catalogue Number: 72200147
• Device Lot Number: 50797275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1