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

Catalog Number	72201992
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8324872
• Report Number: 1219602-2019-00167
• Device Sequence Number: 2106283
• Product Code: JDR
• UDI-Device Identifier: 03596010615534
• UDI-Public: 03596010615534
• Combination Product (Y/N): N
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2022
• Device Catalogue Number: 72201992
• Device Lot Number: 50653516
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1