MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON,CL ULTRA, 35MM; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72200150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that endobutton loop broke as the graft was being pulled up through the tibial tunnel.Loop debris and button had to be retrieved from joint.No significant delay or patient injury reported.
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.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ENDOBUTTON,CL ULTRA, 35MM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7052749
• Report Number: 1219602-2017-01459
• Device Sequence Number: 977584
• Product Code: GAT
• UDI-Device Identifier: 03596010597298
• UDI-Public: (01)03596010597298(17)200911(10)50565461
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2018

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: 09/11/2020
• Device Model Number: 72200150
• Device Catalogue Number: 72200150
• Device Lot Number: 50565461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1