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

Model Number	7207323
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tendon broke when it was being pulled into the femoral tunnel with a hernia plate.No significant delay or patient injury reported.
Additional Manufacturer Narrative
One 20mm endobutton cl was returned for evaluation.Visual assessment of the device shows the cl has been cut.The condition of the cl indicates it was cut free from the tendon after the reported failure of the tendon.

• Brand Name: ENDOBUTTON CL 20MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7593996
• Report Number: 1219602-2018-00726
• Device Sequence Number: 1624190
• Product Code: MBI
• UDI-Device Identifier: 03596010388278
• UDI-Public: (01)03596010388278(17)200810(10)50561216
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 08/10/2020
• Device Model Number: 7207323
• Device Catalogue Number: 7207323
• Device Lot Number: 50561216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 45