MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULR 5.5 PK SUT, SL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203776
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal inserter broke.The anchor was successfully implanted.Broken piece was removed.No issues of any kind were reported and there was not significant delay and no patient injuries.
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.
Additional Manufacturer Narrative
Event or problem description updated.
Event or Problem Description
It was reported that the metal inserter broke.The anchor was successfully implanted even though shaft broke.Broken piece was removed.A 4.5 spade tip bit was used to prepare the insertion site.4.5 drill and 5.5 anchor were used.No issues of any kind were reported and there was not significant delay and no patient injuries.

• Brand Name: FOOTPRINT ULR 5.5 PK SUT, SL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8100011
• Report Number: 1219602-2018-01608
• Device Sequence Number: 16577398
• Product Code: MBI
• UDI-Device Identifier: 00885554029413
• UDI-Public: 00885554029413
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123579
• 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,Followup
• Report Date (Section B): 12/28/2018

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: 03/06/2023
• Device Catalogue Number: 72203776
• Device Lot Number: 2011667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 12/27/2018
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 11/25/2018; 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1