MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORCI SCRW 7MM(7MM HD)X20MM; SCREW, FIXATION, BONE

Catalog Number	7207916
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, when they were placing the tibia screw through the nitinol guide, the screw broke and all the broken pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One (b)(4) biorci 7x20mm screw reported on.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.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Use of other than recommended prep instrument size or types.2.Getting entangled up with other instruments or devices.3.Stripping or over-torque.4.Damaged prep instruments.5.Unexpected bone density/condition.
Additional Manufacturer Narrative
One 7207916 biorci 7x20mm screw returned.The complaint stated: ¿when they were placing the tibia screw through the nitinol guide, the screw broke.¿ the product was received fractured.There were two portions received.The head and partial threads and a small section of thread material.They were torn and shredded.The head indicates early stripping symptoms.The conditions are consistent with excess torque applied and entanglement with a guidewire or other instrument.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: BIORCI SCRW 7MM(7MM HD)X20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8361847
• Report Number: 1219602-2019-00226
• Device Sequence Number: 11099171
• Product Code: HWC
• UDI-Device Identifier: 03596010000897
• UDI-Public: 03596010000897
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2019

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: 04/06/2023
• Device Catalogue Number: 7207916
• Device Lot Number: 50725426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/26/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/03/2019; 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1