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

Catalog Number	7209016
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an acl surgery the tip of the screw broke.The procedure was completed with a backup device with no delay or patient injury reported.All the pieces were removed, the back up device was used in the same bone hole.
Additional Manufacturer Narrative
The reported 10x25 biorci-ha screw, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product has not been returned and the pertinent clinical details have not been provided.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 use, causing debris to enter the joint space.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: the starter must be utilized with the biorci¿ha screws to minimize screw breakage during insertion.The instruction for use (instructions for use) was reviewed and was found to outline 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.
Additional Manufacturer Narrative
One used 10x25mm biorci ha screw was returned for evaluation.Visual assessment of the device confirmed the reported complaint of breakage.Approximately 5mm of one half of the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specification.With the limited clinical details provided regarding graft type, size and tunnel size an exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: not preparing the insertion site with the recommended starter or tap.Excessive force placed on the screw during insertion.Incorrect screw to tunnel size.The instruction for use were reviewed and were found to outline 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.

• 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: 8458297
• Report Number: 1219602-2019-00357
• Device Sequence Number: 3014075
• Product Code: HWC
• UDI-Device Identifier: 03596010460035
• UDI-Public: 03596010460035
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: IT
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

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: 08/03/2023
• Device Catalogue Number: 7209016
• Device Lot Number: 50751050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/29/2019; 10/30/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/30/2019; 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1