MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203841
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the device broke inside the patient's anatomy.Broken pieces were not retrieved as per customer report.Back-up device was available.No patient injury reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: patient information surgical procedure/post-operative care review device labeling (including technique guides, ifus, etc.) conclusion: it is unknown which part of the device was retained.If the retained suture-fix ul anr material is par of the anchor then it is comprised of a biocompatible material but if it¿s a piece of the instrument then its only been approved for limited tissue/bone exposure.Based on the product evaluation the root cause of the suturefix ul anr breakage is contributed to a user vs procedural event.Since, the location of the retained suturefix ul anr is unknown, we are unable to determine if corrosion/ or micro-motion is possible.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted at this time.Approved by (b)(6) md on (b)(4) 2018.Conclusion: it is unknown which part of the device was retained.If the retained suture-fix ul anr material is par of the anchor then it is comprised of a biocompatible material but if it¿s a piece of the instrument then its only been approved for limited tissue/bone exposure.Based on the product evaluation the root cause of the suturefix ul anr breakage is contributed to a user vs procedural event.Since, the location of the retained suturefix ul anr is unknown, we are unable to determine if corrosion/ or micro-motion is possible.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted at this time.Approved by (b)(6) md on (b)(4) 2018.

• Brand Name: SUTUREFIX UL ANR XL W/1 #2 ULTRABRIAD BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8081058
• Report Number: 1219602-2018-01580
• Device Sequence Number: 1771131
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: 00885554030051
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K122059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 06/13/2023
• Device Catalogue Number: 72203841
• Device Lot Number: 50741390
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1