MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RCI SCREW; DEVICE, GENERAL MEDICAL

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/11/2018

Event Type  Injury  

Event Description

It was reported that during a clinical study related to ischiofemoral hip ligament reconstructions for recurrent posterior total hip joint dislocations using 7mm rci screw, a patient died for unknown reasons after follow-up with the medical practitioner.There is no information that relates the death to the use of the device and it is known that the patient had previous clinical history related to hip issues.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H2, h6.The allegation was based upon a report study case from over eight years ago.Bio rci products of unconfirmed code or lot number were referenced as used in treatment.No product was returned.Due to unavailability, evaluation was limited, but recollection by one of the attending physicians believed that the patient passed due to an unrelated cause.If further information becomes available, the complaint may be revisited.Per the instructions for use, preparation is critical for ease of insertion and successful anchoring.Per ifu: "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.¿ factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Adherence to the instructions for use recommendations.2.Use of other than recommended prep instrument size or types.3.Taper or larger head to body design miscalculation.4.Entanglement with other instruments or devices.5.Stripping or over-torque.6.Damaged prep instruments.7.Unexpected bone density/condition.Three year query of complaint history review indicated no similar allegations for the family reported.Batch review was unattainable without a valid lot number reported.Instruction for use documentation contains precautionary statements and recommendations for proper use of product.Risk management files contain the reported failure.Various quality checks are in place to ensure that the material of the device meets requirements defined and validated in the design process.There was no indication of a material factor relating to the reported failure.Post market surveillance activities continue to monitor failure modes reported.No evidence suggests product from this family did not pass requirements upon release for use.At this time, there is no evidence to suggest a direct link between product used during the procedure and the patient outcome reported.

• Brand Name: RCI SCREW
• Type of Device: DEVICE, GENERAL MEDICAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10423199
• MDR Text Key: 203448936
• Report Number: 3003604053-2020-00080
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death