MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 10X25 STERILE; SCREW, FIXATION, BONE

Model Number	7209016
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an acl surgery, the biorci screw failed.The screw was not forwarding and when tried, the tip of the screw broke.All pieces were removed from the patient.The procedure was completed without delay using a back-up device in the same bone hole.No patient injury 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
The additional information updated in the last report (1219602-2020-00558 001) was received on 31-mar-2020.
Event or Problem Description
It was reported that during an acl surgery, the biorci screw failed.The screw was not forwarding and when tried, the tip of the screw broke in the tibial tunnel.All pieces were removed from the patient.The procedure was completed without delay using a back-up device in the same bone hole.No patient injury 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
H10: additional information on b5.
Additional Manufacturer Narrative
H2, h6.One 7209016 scr biorci-ha 10x25 sterile implant reported on was used in treatment but not returned.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper use of device or excessive force.The instructions for uses states: ¿excessive force should not be placed on the delivery instrument¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.A review of complaints and manufacturing batch records was preformed, no other complaints of this failure was found.

• Brand Name: SCR BIORCI-HA 10X25 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9894759
• Report Number: 1219602-2020-00558
• Device Sequence Number: 19438272
• Product Code: HWC
• UDI-Device Identifier: 03596010460035
• UDI-Public: 03596010460035
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2020

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: 07/18/2024
• Device Model Number: 7209016
• Device Catalogue Number: 7209016
• Device Lot Number: 50817341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020; 03/31/2020; 03/31/2020
• Initial Report FDA Received Date: 03/28/2020
• Supplement Report FDA Received Date: 04/03/2020; 04/06/2020; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1