MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR 2.9 WITH 2 ULTRABRAID; SCREW, FIXATION, BONE

Catalog Number	72200775
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bioraptor 2.9 with 2 ultrabraid broke.A back up device was utilized to complete the procedure.No patient injury or complications were reported.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the device.

• Brand Name: BIORAPTOR 2.9 WITH 2 ULTRABRAID
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6447672
• Report Number: 1219602-2017-00353
• Device Sequence Number: 13797579
• Product Code: HWC
• UDI-Device Identifier: 03596010585967
• UDI-Public: (01)03596010585967(17)180813(10)50561615
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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 Catalogue Number: 72200775
• Device Lot Number: 50561615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 05/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1