MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W. UB COBRAID BLUE; STAPLE, FIXATION, BONE

Catalog Number 72201993

Device Problem Break (1069)

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

Event Date 11/21/2013

Event Type  malfunction  

Manufacturer Narrative

Evaluation was not possible, as the device will not be returned.A review of the device history records was performed which confirmed no inconsistencies.A complaint history review has not identified additional complaints for this lot number on file.There were no internal processing issues which could have contributed to the nature of the complaint.Due to these facts we are unable to determine what may have caused the user to experience the reported incident.No further investigation is warranted at this time.(b)(4).

Event Description

During a superior labrum anterior and posterior repair utilizing the osteoraptor 2.3 w.Ub cobraid blue it was reported that while tying a knot, it broke.A back up device was available to complete the case.The suture was completely removed from the patient and the anchor was left in.The surgeon then drilled another hole and used a competitor's device to finish.An accupass left and a knot pusher were being used as the ancillary devices.There were no reported patient injuries or complications.

• Brand Name: OSTEORAPTOR 2.3 W. UB COBRAID BLUE
• Type of Device: STAPLE, FIXATION, BONE
• 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: 4939218
• MDR Text Key: 22889989
• Report Number: 1219602-2015-00447
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2018
• Device Catalogue Number: 72201993
• Device Lot Number: 50476199
• Other Device ID Number: 350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2013
• 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