MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK; STAPLE, FIXATION, BONE

Catalog Number 72201992

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/16/2013

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 this fact 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 hip procedure utilizing the osteoraptor 2.3 w/ 1 ub cobraid black, it was reported that the sutures broke on three devices.1st one suture broke when passing.2nd one suture broke when tying down and 3rd one suture broke after tying down.A back up device was available to complete the case.It was reported that the anchor was left in bone, broke above knot and anchor broke before knot.Arthropierce used to pass suture and a quick t knot pusher.In all instances, the suture breakage made the anchor fail.It was confirmed that all suture was removed.There were no reported patient injuries or complications.

• Brand Name: OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK
• 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: 4939233
• MDR Text Key: 22886691
• Report Number: 1219602-2015-00446
• 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: Other
• Report Date: 07/16/2015

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: 07/30/2018
• Device Catalogue Number: 72201992
• Device Lot Number: 50472391
• Other Device ID Number: 297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2013
• 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