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

Catalog Number 72202901

Device Problem Torn Material (3024)

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

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a rotator cuff repair procedure, the suture of the footprint anchor sheared in-half when threading the eyelet.The anchor ans suture was removed from the patient with the use of tweezers.A backup anchor of the same model was implanted into the same bone hole to complete the procedure.No patient injuries or complications were noted as a result.

Manufacturer Narrative

Visual assessment of the device shows the anchors orientation on the inserter is 90 degrees from its customary positon.Three of the anchor fins are missing.Inserter was functionally tested and the inner plug moved within the anchor as intended.The stay suture and suture threader suture are both broken.It appears that then stay suture was inadvertently cut during tensioning of the repair suture.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.Further investigation is not warranted at this time.

• 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 ; 7000 w william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 6000207
• MDR Text Key: 56485338
• Report Number: 1219602-2016-01149
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2020
• Device Catalogue Number: 72202901
• Device Lot Number: 50549280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 49 YR
• Patient Weight: 60