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

Catalog Number	72203783
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during an unknown procedure, the footprint split in two upon insertion.It is unknown if a back up device was available or if a delay was caused due to the device malfunction, but no patient injuries were reported.
Additional Manufacturer Narrative
The reported 4.5 footprint ultra pk suture anchor assembly intended for use in treatment, will not be returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the anchor broke in two pieces.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: off axis insertion, not preparing the insertion site properly prior to insertion.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.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 boulevard; mansfield MA 02048
• MDR Report Key: 8813455
• Report Number: 1219602-2019-00850
• Device Sequence Number: 2417386
• 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): 08/06/2019

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: 02/16/2024
• Device Catalogue Number: 72203783
• Device Lot Number: 2027503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1