MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULR 4.5 PK SUT SL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72203783
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee procedure, the green retention suture of the footprint did not hold the anchor on the inserter, causing the anchor to fell off straight out of the packet inside the patients anatomy.It was removed with forceps.The procedure was successfully completed without significant delay using a back-up device in an additional bone hole.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 4.5 footprint ultra pk suture anchor assembly, used in treatment, will not be returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the stay suture did not hold the anchor on the inserter.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: inadvertent loosening or dislodgement of the stay suture from the handle.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: FOOTPRINT ULR 4.5 PK SUT SL
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10369247
• Report Number: 1219602-2020-01177
• Device Sequence Number: 3463719
• Product Code: MBI
• UDI-Device Identifier: 00885554029406
• UDI-Public: 00885554029406
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123579
• 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): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2023
• Device Model Number: 72203783
• Device Catalogue Number: 72203783
• Device Lot Number: 50776632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention