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

Catalog Number 72201992

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/09/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(6) other, no product returned for evaluation.Method: product not returned for the evaluation.Evaluation was not possible, as the device will not be returned.A review of the device history records was performed.One record was found for an unrelated failure mode.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 hip arthroscopy using the osteoraptor 2.3 w/ 1 ub cobraid black it was reported that the suture broke upon tying the knot around the labrum; he used another with success.The anchor did not break and was left in situ.The introducer was discarded.A new hole was drilled for the new anchor.There was a two minute procedural delay and no reported patient injuries or complications.

• Brand Name: OSTEORAPTOR 2.3 W/ 1 UB COBRAID
• 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: 4939232
• MDR Text Key: 22890465
• Report Number: 1219602-2015-00448
• 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

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 72201992
• Device Lot Number: 50479062
• Other Device ID Number: 236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/18/2013
• 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