MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W. UB COBRAID BLUE; ACCESSORIES, ARTHROSCOPIC

Catalog Number 72201993

Device Problems Component Falling (1105); Loose or Intermittent Connection (1371); Fitting Problem (2183)

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

Event Date 01/10/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6).An investigation was not able to be performed, as the device was not received.In the event the device is located, a complete evaluation will be made.A review of the device history records and quality records associated with this manufactured lot confirmed that no abnormalities were reported with this product during manufacture, the components passed the manufacturing and quality verifications.(b)(4).

Event Description

It was reported that during an ankle arthroscopy procedure using osteoraptor 2.3 w.Ub cobraid blue two anchors did not fit into the patient's bone and fell out.The loose anchors were removed from the patient.It is unknown if there was a procedural delay.The procedure was completed using a 2.9mm third anchor using the same hole.This incident did not result in any patient injury.

• Brand Name: OSTEORAPTOR 2.3 W. UB COBRAID BLUE
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 5029742
• MDR Text Key: 24821673
• Report Number: 1219602-2015-00910
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 02/04/2014

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: 07/31/2018
• Device Catalogue Number: 72201993
• Device Lot Number: 50471052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Date Device Manufactured: 08/08/2013
• 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