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

Catalog Number 72201992

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/23/2019

Event Type  malfunction  

Event Description

It was reported that during a hip labrum repair procedure, the surgeon was use a 2.3mm surgical technique but the patient bone was soft enough to put out the anchor from the patient.After that, the surgeon was removed the implant from the patient and a backup implant was used to finish successfully and without a delay.

Manufacturer Narrative

One (b)(4) osteoraptor 2.3 suture anchor reported on.The complaint stated: ¿the anchor was pulled out of the patient bone, which was a bit soft.¿ due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were not possible without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.

• 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: jim gonzales ; 7000 west william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 8324872
• MDR Text Key: 136318290
• Report Number: 1219602-2019-00167
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010615534
• UDI-Public: 03596010615534
• Combination Product (y/n): N
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

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: 03/17/2022
• Device Catalogue Number: 72201992
• Device Lot Number: 50653516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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