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

Model Number	72203783
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the hole at the end of the anchor was not allowing any sutures through.The surgeon tried several times and ended up opening a new anchor which worked perfectly.No patient injury was reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
After analyzing it, the investigator found no problem in the returned device.Visual assessment of the device shows the anchor remains attached to the inserter with the stay suture.The suture threader has been removed.Dimensional assessment of the anchors suture slot confirmed it meets print specifications.Functional assessment confirmed the inner plug was able to be advanced and retracted as intended.The anchor also excepted two strands of ultrabraid suture.This investigation could not identify any evidence of product contribution to the reported complaint.

• 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: 7232801
• Report Number: 1219602-2018-00186
• Device Sequence Number: 10798093
• Product Code: MBI
• UDI-Device Identifier: 00885554029406
• UDI-Public: (01)00885554029406(17)210804(10)50614268
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2018

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: 08/04/2021
• Device Model Number: 72203783
• Device Catalogue Number: 72203783
• Device Lot Number: 50614268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 02/28/2018; 02/28/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/02/2018; 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1