MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA - PK; FOOTPRINT ULTRA PK SUT ANC 4.5

Model Number 72202901

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

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

Event Date 08/15/2014

Event Type  malfunction  

Event Description

During a hip arthroscopy using the footprint ultra pk suture anchor, 4.5 it was reported that the anchor broke intra-operatively, the proximal end (eyelet) of the anchor broke.They were not able to locate the remainder (irrigation, x-ray, suction bags etc.) of the device which was outside of the joint space.The site prep was done with a 2.3 drill guide only ¿ the surgeon did not use the 3.8 tapered awl.The surgery was completed with a 5.5 anchor.No holes were left empty.There was a reported 15-20 minute procedural delay while they tried to locate the broken piece of the anchor.Nothing will be returned for analysis.

Manufacturer Narrative

Smith & nephew, inc.Endoscopy div.; is submitting the enclosed report to comply with 21 cfr no product is being returned for analysis.(b)(4).

• Brand Name: FOOTPRINT ULTRA - PK
• Type of Device: FOOTPRINT ULTRA PK SUT ANC 4.5
• 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: donna lanteigne ; 150 minuteman road; andover, MA 01810 ; 9787491576
• MDR Report Key: 4068333
• MDR Text Key: 4734930
• Report Number: 1219602-2014-00274
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: 50507220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2014
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1