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	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the anchor broke upon insertion.No patient injury was reported.A backup device was used to complete the surgery.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Examination is not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.

• 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: 7705079
• Report Number: 1219602-2018-00900
• Device Sequence Number: 1409613
• Product Code: MBI
• UDI-Device Identifier: 00885554029406
• UDI-Public: (01)00885554029406(17)230404(10)50725159
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2018

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 Model Number: 72203783
• Device Catalogue Number: 72203783
• Device Lot Number: 50725159
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1