MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X30MM STRL BX 1; SCREW, FIXATION, BONE

Catalog Number	7207561
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw broke while tightening.There was not delay on the procedure and a back-up was available to complete the procedure.Unknown if the pieces were retrieved from the patient.No patient injury was reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.

• Brand Name: SCR BIORCI 8X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8135882
• Report Number: 1219602-2018-01676
• Device Sequence Number: 19310436
• Product Code: HWC
• UDI-Device Identifier: 03596010426239
• UDI-Public: 03596010426239
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K992396
• 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): 01/24/2019

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: 12/20/2021
• Device Catalogue Number: 7207561
• Device Lot Number: 50637503
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1