MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1; SCREW, FIXATION, BONE

Model Number	7207554
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported about a 7x25mm biorci screw that, during a procedure, after performing the tunnels with the drill in the femoral part for fixing the 9.5mm hth graft, at that moment when the screw was going through the passing pin, this one broke.All the fragments were removed using the same screwdriver and a kelly clamp.The procedure was successfully completed without delay using a sofsilk screw back-up device.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 7207554 scr biorci 7x25mm (7mm head) strl bx 1 intended for use in treatment has been returned for evaluation.The information provided states: ¿during a procedure, after performing the tunnels with the drill in the femoral part for fixing the 9.5mm hth graft, that at that moment when the screw was going through the passing pin, this one broke.All the fragments were removed using the same screwdriver and a kelly clamp¿.The implant was returned fractured.The distal threads have been chewed up.The physical condition indicates difficulty with proper insertion; contact with another device and torque placed upon the implant.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.Further investigation is not warranted at this time.

• Brand Name: SCR BIORCI 7X25MM (7MM HEAD) STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9665856
• Report Number: 1219602-2020-00167
• Device Sequence Number: 16836103
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: 03596010426185
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 10/04/2023
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50762624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1