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 06/19/2013

Event Type  malfunction  

Manufacturer Narrative

Other, no product returned for evaluation.Method : product not returned for the evaluation.Evaluation was not possible, as the devices are 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 these lot numbers on file.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)(6).(b)(4).

Event Description

During an anterior cruciate ligament reconstruction, using an osteoraptor 2.3 w/ 1 ub cobraid black it was reported that the arthropiece severed the suture both times when passing under the labrum.The suture broke with anchor still in bone twice and was removed with a grasper.The procedure was completed by drilling more holes and putting in more anchors.New holes were drilled as anchors were left in patients bone but not with any suture attached.There was an operative delay of 15 minutes during the procedure.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: 4939221
• MDR Text Key: 22881007
• Report Number: 1219602-2015-00443
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K082215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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: 10/31/2017
• Device Catalogue Number: 72201992
• Device Lot Number: 50436890
• Other Device ID Number: 240
• 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: 11/26/2012
• 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
• Patient Age: 19 YR