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 Consequences Or Impact To Patient (2199)

Event Date 10/20/2014

Event Type  malfunction  

Manufacturer Narrative

Device is not being returned for evaluation.A review of the device history records and quality records associated with this manufactured lot confirmed that one additional complaint has been filed from this facility.No abnormalities were reported with this product during manufacture.(b)(4).

Event Description

It was reported that during a hip procedure, the surgeon was attempting to tighten the knot, when the suture broke.It was reported that the suture broke in the patient.The surgeon removed with grasper.The knot pusher was examined under magnification, and was observed to look it fine.The surgeon elected to remove it from service.The surgeon completed the procedure with a back-up device.The surgeon used the initially drilled hole to insert the back-up device.The patient was reported to be fine post operative.

• 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: 4941921
• MDR Text Key: 23002335
• Report Number: 1219602-2015-00482
• 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: 07/16/2015

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: 02/28/2019
• Device Catalogue Number: 72201993
• Device Lot Number: 50496038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2014
• 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