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

Model Number	7207916
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction, the implant broke while being inserted into the femur.The pieces were removed from the patient.A backup device was available to complete the procedure.No significant delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6: the reported 7207916 7x20mm biorci screw, intended for use in treatment, has been returned for evaluation.From the information provided, the screw broke during insertion.Visual assessment confirms complaint.The screw was returned in fragments.An exact root cause cannot be determined with confidence with the limited clinical details provided; however, factors that could have contributed to the reported event include: not preparing the insertion site with the recommended prep device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.
Additional Manufacturer Narrative
: h3, h6: the reported 7x20mm biorci screw, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the screw broke during insertion.An exact root cause cannot be determined with confidence with the limited clinical details provided; however, factors that could have contributed to the reported event include: not preparing the insertion site with the recommended prep device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.In the event additional information or the device is returned the complaint will be revisited.Further investigation is not warranted at this time.

• 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: 9857202
• Report Number: 1219602-2020-00536
• Device Sequence Number: 2610870
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2020

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 Model Number: 7207916
• Device Catalogue Number: 7207916
• Device Lot Number: 50725426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 06/26/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/03/2020; 06/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1