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

Catalog Number	7207916
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an acl reconstruction surgery, two biorci screws broke into pieces while being inserted into the tunnel.All fragments were retrieved from the patient by using artery and grasper.A back-up device was available to complete the surgery; additional bone holes did not have to be drilled.The surgery was not significantly delayed.The patient was not injured.
Additional Manufacturer Narrative
One 7207916 biorci 7x20mm screw used for treatment, was returned for evaluation.The complaint stated: ¿¿a biorci screw broke into pieces while being inserted into the tunnel.¿ the product was received fractured into multiple pieces.This is not the entire product.The portions were torn and shredded.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.Product met specifications upon release to distribution.
Additional Manufacturer Narrative
Two related biorci 7x20mm screws used for treatment, were not returned for evaluation.Due to unavailability, the allegations could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited 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.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.Prior to use inspect the tip of the driver.If tip flaring is apparent do not use the driver.Excessive force should not be placed on the delivery instrument.If hard bone is encountered, the biorci tap should be used.¿ product met specifications upon release to distribution.Complaint history review found no other reports for this lot.The second device report number is: 1219602-2019-00761.Correction in patient code: should be 2687 instead of 2692.

• 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: 8748807
• Report Number: 1219602-2019-00760
• Device Sequence Number: 13934467
• Product Code: HWC
• UDI-Device Identifier: 03596010000897
• UDI-Public: 03596010000897
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K032224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

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: 06/17/2021
• Device Catalogue Number: 7207916
• Device Lot Number: 50606836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 09/25/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/31/2019; 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1