MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 10X35MM STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207568
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl (anterior cruciate ligament) reconstruction, after fixing the biorci 10x35mm screw to the tibia, when the extended leg was placed, it was noticed that the 10x35mm screw was passing with difficulty and it broke.The broken screw was recovered using a needle holder and a screwdriver.The procedure was successfully completed without significant delay using a back-up biorci 10x30mm screw into the same bone hole.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 7207568 scr biorci 10x35mm strl bx 1intended for use in treatment has been returned for evaluation.The information provided states: ¿during an acl (anterior cruciate ligament) reconstruction, after fixing the biorci 10x35mm screw to the tibia, when the extended leg was placed, it was noticed that the 10x35mm screw was passing with difficulty and it broke.The broken screw was recovered using a needle holder and a screwdriver¿.Visual assesment confirms fractured screw.The distal threads have been chewed up.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied.Per instructions for use: ¿excessive force should not be placed on the delivery instrument¿.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCR BIORCI 10X35MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9696314
• Report Number: 1219602-2020-00196
• Device Sequence Number: 16858987
• Product Code: HWC
• UDI-Device Identifier: 03596010426291
• UDI-Public: 03596010426291
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2020

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: 7207568
• Device Catalogue Number: 7207568
• Device Lot Number: 50725469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 100