MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDBUTN CL BTB STERILE 20MM BOX OF 1; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	7210080
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a procedure at the time of the patellar graft passage, device broke inside the patient, pieces were retrieved from the patient.No delay or patient injuries reported, back-up device available to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H6: the reported 20mm endobutton btb cl, intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the device broke.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper tunnel length to graft length.Improperly sized graft diameter to tunnel diameter.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.Based on the review of device history and complaint history, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: ENDBUTN CL BTB STERILE 20MM BOX OF 1
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9302689
• Report Number: 1219602-2019-01396
• Device Sequence Number: 2104920
• Product Code: MBI
• UDI-Device Identifier: 03596010001214
• UDI-Public: 03596010001214
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/13/2020

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: 05/24/2023
• Device Catalogue Number: 7210080
• Device Lot Number: 2016100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/10/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1