MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HEALICOIL SA PK 4.5MM W/2 UB-BL, CBRD BL; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203378

Device Problem Break (1069)

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

Event Date 02/13/2013

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device is not being returned.Review of the device history records were performed which confirmed no inconsistencies.There were no internal processing issues, which could have contributed to the nature of the complaint.A complaint history review has not identified additional complaints for this lot number on file.Due to this fact it was not possible to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.Missing information from this report is identified as a blank, unknown and as no information (ni).This information was not provided in the reported event or available at the time of report submission.(b)(4).

Event Description

It was reported that during a shoulder arthroscopy procedure using healicoil sa pk 4.5mm w/2 ub-bl, cbrd bl the suture broke while trying to tie the third knot.The broken suture was removed from the patient.There was no procedural delay reported.The procedure was completed using a back-up device.This incident did not result in any patient injury or complications.

• Brand Name: HEALICOIL SA PK 4.5MM W/2 UB-BL, CBRD BL
• 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: 4946313
• MDR Text Key: 23114206
• Report Number: 1219602-2015-00541
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 72203378
• Device Lot Number: 50444977
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• Date Device Manufactured: 12/27/2012
• 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