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	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery, the screw broke while it was being inserted.The procedure was successfully completed without significant delay using a back-up device.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 in b5 and b7.
Event or Problem Description
It was reported that during an acl surgery, the screw broke while it was being inserted.The procedure was successfully completed without significant delay using a back-up device.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
H3, h6: one scr biorci 7x25mm (7mm head) strl bx 1 intended for use in treatment has not been returned for evaluation.Without the reported product, a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided states: ¿ during an acl surgery, the screw broke while it was being inserted¿.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¿.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.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: 9925020
• Report Number: 1219602-2020-00590
• Device Sequence Number: 3354706
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: 03596010426185
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2021

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: 03/01/2024
• Device Model Number: 7207554
• Device Catalogue Number: 7207554
• Device Lot Number: 50790603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/02/2020; 04/29/2020; 06/01/2021
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/16/2020; 05/05/2020; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR