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

Model Number	72200147
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture broke when it was pulled through the femoral tunnel.No patient injury was reported.
Additional Manufacturer Narrative
Examination is not possible, as the device has not been returned.A photograph was sent for evaluation.Examination of the photograph shows the pulling suture has been broken or cut the photo is inconclusive.The investigation could not draw any conclusions about the reported event without the return of the device.
Event or Problem Description
It was reported that the suture broke when it was pulled through the femoral tunnel.A signifant delay greater than 30 minutes was presented.No patient injury was reported.

• 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: 7528650
• Report Number: 1219602-2018-00620
• Device Sequence Number: 11141167
• Product Code: GAT
• UDI-Device Identifier: 03596010597267
• UDI-Public: (01)03596010597267(17)220630(10)50672425
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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: 06/30/2022
• Device Model Number: 72200147
• Device Catalogue Number: 72200147
• Device Lot Number: 50672425
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/20/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1