MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR, 5.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72202902

Device Problem Disconnection (1171)

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

Event Date 10/31/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Reportedly, the surgeon attempted to insert anchor after hole preparation, the sutures got tangled around the barbs of anchor and upon trying to remove anchor from joint through cannula the anchor became disconnected from distal inserter.The surgeon attempted to insert anchor but was unsuccessful.The surgeon reportedly tied down sutures and decided against a double row repair.

Manufacturer Narrative

Device returned to the manufacturer on (b)(6) 2015 evaluation narrative - one 5.5 ultra pk footprint anchor assembly was returned for evaluation.Visual assessment showed the inner shaft to be bent.This condition is consistent with off axis insertion.The off axis insertion likely caused the misalignment of the sutures during insertion.Anchor was returned intact.Dimensional assessment of the anchor found it met print specifications.Per the device ifu ¿slide the loaded suture anchor either percutaneously or through a cannula, depending on technique preference.Minimize suture entanglement by removing excess suture slack and advance the anchor to the prepared bone site.If desired, secure the free ends of the suture using the features located on the inserter handle.Do not attempt to tension the suture(s) at this time.Orient the anchor such that the free limb sutures entering the anchor are facing the tissues and the sutures are not twisted around the anchor.Establish and maintain axial alignment of the suture anchor to the prepared insertion site, and place the tip of the anchor into the prepared hole¿.No further investigation is required.This event was a product problem rather than an adverse event.Device was evaluated by the manufacturer.(b)(4).

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR, 5.5
• 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 ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5250262
• MDR Text Key: 32306270
• Report Number: 1219602-2015-01219
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2020
• Device Catalogue Number: 72202902
• Device Lot Number: 50554899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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