MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 9X25MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207563
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scr biorci 9x25mm was broken, identified during the procedure.No patient injury or delay.S&n back-up device used to complete the procedure.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.The customer provided images confirm that device was broken.A review of the device history 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.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force during implementation.Internal complaint reference: case-2020-00024960-1.
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 visual inspection found the tip of the screw has been broken.The customer provided images confirm that device was broken.Based on the condition of the product material found during visual inspection it was determined that additional material testing was not required.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 the raw material, found that the material certificate of analysis required.The complaint was confirmed.Factors that could have contributed to the reported event include excessive force or torque, off-axis insertion, or improper preparation of the insertion site.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI 9X25MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10813739
• Report Number: 1219602-2020-01808
• Device Sequence Number: 19836346
• Product Code: HWC
• UDI-Device Identifier: 03596010426253
• UDI-Public: 03596010426253
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2021

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: 01/04/2024
• Device Model Number: 7207563
• Device Catalogue Number: 7207563
• Device Lot Number: 50779633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 08/12/2021
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/10/2020; 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1