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	Foreign Body In Patient (2687)
Date of Event	02/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon used a suturefix xl anchor during a surgery.The case went well and the anchor deployed.However, on the x-ray during the procedure a small mark was visible on the image.On further imaging after surgery it appears that it is a tiny piece of metal from the anchor (probably the insertion prong).The patient has had no pain and the metal prong appears to be under the anchor and in the bone.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.An image (x-ray) was supplied but is inconclusive.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.Without the relevant clinical information, procedure report, the anchor insertion instrumentation prong, a root cause of the reported insertion prong breakage cannot be concluded.The suturefix anchor insertion prong is biocompatible and it is retained within the original bone.However, migration is not likely since the broken insertion prong is contained within the bone as the single image appears.It was communicated that while the material itself is relatively inert, the possibility of mechanical irritation from a metallic fragment cannot be excluded.Per report, the patient is recovering well and has no pain or mobility issues.

• 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: 8239218
• Report Number: 1219602-2019-00061
• Device Sequence Number: 1946820
• Product Code: MBI
• UDI-Device Identifier: 00885554030051
• UDI-Public: 00885554030051
• Combination Product (Y/N): N
• PMA/510(K) Number: K122059
• 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): 04/30/2019

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 Catalogue Number: 72203841
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1