MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202901

Device Problems Device Slipped (1584); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could the root cause be determined with confidence.There are no indications that would suggest the device did not meet product specifications upon release into distribution.

Event Description

During surgery the doctor drilled the holes and pounded the anchors in correctly, but anchors kept pulling out.The surgeon ended up using some footprint knotless anchors to fill the holes from the bioraptor knotless.It appears as though the anchors would not disengage from the shaft/handle.No patient injury or other complications were reported.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5968111
• MDR Text Key: 55676419
• Report Number: 1219602-2016-00831
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/18/2015

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
• Device Operator: Other
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: 72202901
• Device Lot Number: 50554874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 09/21/2016
• Date Device Manufactured: 07/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1