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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when the package was opened, it was noticed that the loop was loose and fluffed already.There was no backup device available.No delay or patient injury 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.There was no relationship confirmed between the reported event and the device.There is no objective evidence to suggest a direct link between the symptoms and product used during the procedure.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.Finesse and care is necessary with handling this product.The nature of the filament fiber is extremely fine.The product is subject to fluffing upon removal from the package.Risk management documentation defines this condition as a perceived flaw.There is no detriment to safety, efficacy or design intent.If objective evidence or relevant information becomes available to assist with evaluation the complaint will certainly be revisited.This was considered an isolated occurrence as there have been no other complaints affiliated with this lot.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: 8923310
• Report Number: 1219602-2019-01004
• Device Sequence Number: 1904129
• Product Code: MBI
• UDI-Device Identifier: 03596010001214
• UDI-Public: 03596010001214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/24/2019

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: 09/17/2023
• Device Catalogue Number: 7210080
• Device Lot Number: 50759299
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1