MAUDE Adverse Event Report: SCR BIORCI-HA 9X35 STERILE; SCREW, FIXATION, BONE

Model Number	7207683
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the surgery while the biorci screw was being deployed it broke off.No delay or other complications were reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the drawing found the device is visually inspected using a magnification lamp for embedded particulates, dust, contaminants, foreign matter, voids, and sinks.A certification of compliance or evidence of conformance to material and process specifications is required.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10 h3, h6 the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the polymer found that the storage requirements for the material are specified, and the material must comply with provided percentage composition specifications as measured by ash test.The device was returned in the original packaging.The distal tip of the returned screw is broken.Based on the condition of the product material found during visual inspection, additional material testing is not required.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force on the device, excessive torque on the device, attempted correction of a damaged device, off-axis insertion, improper preparation of the insertion site, or an inadvertent impact event.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: SCR BIORCI-HA 9X35 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• MDR Report Key: 11542292
• Report Number: 1219602-2021-00591
• Device Sequence Number: 4087404
• Product Code: HWC
• UDI-Device Identifier: 03596010460028
• UDI-Public: 03596010460028
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2023
• Device Model Number: 7207683
• Device Catalogue Number: 7207683
• Device Lot Number: 50725507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 02/27/2021
• Supplement Date Received by Manufacturer: 04/16/2021; 11/02/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/17/2021; 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention