MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTUREFIX CRVD AHR S 1 #2 UB STR BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72204687
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the shoulder labral repair, the suture fix broke inside the drill guide.The procedure was successfully completed with a back up device and no delay reported.It broke inside the patient but the pieces were removed.No patient injury was reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be 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.

• Brand Name: SUTUREFIX CRVD AHR S 1 #2 UB STR BL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8236906
• Report Number: 1219602-2019-00054
• Device Sequence Number: 1558296
• Product Code: MBI
• UDI-Device Identifier: 00885556686287
• UDI-Public: 00885556686287
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K163034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: 04/26/2021
• Device Catalogue Number: 72204687
• Device Lot Number: 50730005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1