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

Catalog Number	72200775
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the implant broke inside the joint.All pieces were removed from the patient and the procedure was completed with a backup device following a short delay.No patient impact was reported.
Additional Manufacturer Narrative
Device investigation narrative - due to no product being returned, evaluation, and investigation are not possible.No definitive conclusions can be made without pertinent manufacturing information or a device to evaluate.See communications for timeline.No further actions can be taken at this time.If relevant information becomes available to assist with traceability, the complaint will be revisited.(b)(4).

• 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: 6533109
• Report Number: 1219602-2017-00443
• Device Sequence Number: 616375
• Product Code: HWC
• UDI-Device Identifier: 03596010585967
• UDI-Public: (01)03596010585967(17)180115(10)50534421
• 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: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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 Expiration Date: 02/06/2018
• Device Catalogue Number: 72200775
• Device Lot Number: 50534421
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2017
• Supplement Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR