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	09/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a crossed ligament surgery, the graft was passed through the tunnels, threads that guide the endobutton plate were traced and an appropriate lock of the plate was achieved in the previous cortical.At the time of pulling the graft down to verify the stability of the graft, the endobutton polyester loop was broken, producing in this way the failure of the technique and returning through the graft tunnels.A backup device was available to complete the procedure.The surgical had a delay greater than 2 hours.Patient injuries were not reported.
Additional Manufacturer Narrative
One 7210080 sterile bone tendon bone 20mm continuous loop endobutton used for treatment, was not returned for evaluation.Due to product unavailability, physical evaluation, full investigation and conclusions were limited.Factors affecting device performance include: device ability, surgical ability and conformance with instructions for use which includes specific instructions, recommendations and precautionary statements for proper use of product.Influences unrelated to manufacture that could compromise product performance or integrity include: 1) alternate prep method, instruments or method used.2) incompatible or unexpected bone density/condition.3) inadvertent stress, pressure or excess torque applied.4) inadequate tunnel diameter or length.If objective evidence or relevant information becomes available to assist with evaluation the complaint will certainly be revisited.There have been no other complaints affiliated with this lot.Procedural information was included.No information supported or confirmed product failure.Product met specifications upon release to distribution.Complaint history review found no other reports for this lot.

• 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: 9157210
• Report Number: 1219602-2019-01207
• Device Sequence Number: 2308036
• Product Code: MBI
• UDI-Device Identifier: 03596010001214
• UDI-Public: 03596010001214
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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: 05/25/2023
• Device Catalogue Number: 7210080
• Device Lot Number: 50737282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 88