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

Catalog Number 72202901

Device Problems Break (1069); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2016

Event Type  malfunction  

Manufacturer Narrative

No evaluation conducted to date, awaiting receipt of device.(b)(4).

Event Description

It was reported that during an rcr procedure, the anchor was deployed but broke off into the joint space and an additional bone hole was required.The broken piece was retained in the patient.The anchor was removed from the patient.A backup device was utilized to complete the procedure.

Manufacturer Narrative

Visual assessment of the inserter shows the inner shaft is bent approximately 45 degrees.The proximal portion of the anchor remains attached to the tip of the inserter.Dimensional assessment of the inner shaft confirmed it met print specifications.The condition of the device is consistent with off axis insertion.After the evaluation the root cause for the reported issue was determined to be user error.A review of the device history record was performed which confirmed no inconsistencies.

• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 5927008
• MDR Text Key: 54528557
• Report Number: 1219602-2016-00558
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K113274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2021
• Device Catalogue Number: 72202901
• Device Lot Number: 50606526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2016
• 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