MAUDE Adverse Event Report: SMITH & NEPHEW, INC. IT WAS REPORTED THAT DURING A REPAIR PROCEDURE, THE SCREW WAS BROKEN IN AN INCOM; SCREW, FIXATION, BONE

Model Number	7207568
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a repair procedure, the screw was broken in an incomplete longitudinal way, the graft was fixed without any problem in the patient.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Additional Manufacturer Narrative
One 10x35mm biorci screw was returned for evaluation.Visual assessment of the screw showed the distal threads are slightly deformed.This deformity is consistent with being implanted.Further examination of the screw using a stereo microscope showed no abnormalities (cracking, breakage).This investigation could not identify any evidence of product contribution to the reported complaint.Additional information on.
Event or Problem Description
It was reported that during a repair procedure, the screw was broken in an incompleted longitudinal way, the graft was fixed without any problem in the patient.All the pieces were removed from the patient.A backup device was available to complete the procedure with no delay or patient injuries.

• Brand Name: IT WAS REPORTED THAT DURING A REPAIR PROCEDURE, THE SCREW WAS BROKEN IN AN INCOM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7714672
• Report Number: 1219602-2018-00913
• Device Sequence Number: 13785454
• Product Code: HWC
• UDI-Device Identifier: 03596010426291
• UDI-Public: (01)03596010426291(17)220407(10)50657531
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K992396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 04/07/2022
• Device Model Number: 7207568
• Device Catalogue Number: 7207568
• Device Lot Number: 50657531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 01/08/2019
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 09/04/2018; 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR