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

Catalog Number	7207554
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an acl reconstruction surgery, the biorci screw broke at the front end.All fragments were retrieved from the patient by using tweezers.A back-up device was used, in the same bone hole, to complete the procedure.The surgery was not significantly delayed.The patient was not injured.
Additional Manufacturer Narrative
One 7207554 sterile biorci pla 7x25mm screw used for treatment, was returned for evaluation.The complaint stated: ¿the biorci screw broke at the front end." dimensional inspection confirmed that this was a 7x25mm product.The implant was returned fractured.The distal threads have been chewed up.There is approximately 3mm missing from the distal tip.The piece was not returned although the report indicated that all fragments were retrieved.The symptoms are consistent with entanglement with a guidewire or other instrument.The star hex was intact.The physical condition indicates difficulty with proper insertion; contact with another device and torque placed upon the implant.Adherence to the instructions for use prep and use is essential for optimum success of the product.This product contains a technique oriented information per instructions for use ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.The starter must be utilized with the biorci screws to minimize screw breakage during insertion.Prior to use inspect the tip of the driver.If tip flaring is apparent do not use the driver.Excessive force should not be placed on the delivery instrument.If hard bone is encountered, the biorci tap should be used.¿ complaint search revealed no other complaints for the history of this production lot.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• 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: 8786748
• Report Number: 1219602-2019-00797
• Device Sequence Number: 1689484
• Product Code: HWC
• UDI-Device Identifier: 03596010426185
• UDI-Public: 03596010426185
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/05/2019

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: 12/13/2022
• Device Catalogue Number: 7207554
• Device Lot Number: 50702512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1