MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 9X30 STERILE; SCREW, FIXATION, BONE

Model Number 7207682

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported that during an unspecified surgery, it was noticed the external box of the 'biorci' screw was in perfect state, but the internal box was opened.The device did no have contact with the patient.The procedure was completed with no delay using a smith and nephew back up device.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Manufacturer Narrative

H3, h6: the reported device was received for evaluation.There was no way to determine if the device contributed to the reported event.A review of the customer provided image found labelling confirming the product identification information.The inner pouch is opened and the edges appear curled.A visual inspection of the returned device found that it is not in its original packaging.The carton, pouch, and screw were returned, but the paper carrier was not.The foil pouch shows signs of being previously sealed, and is opened all the way down the sides.The edges of the pouch are curled and bent.There is some debris on the device, and there are light markings on the inside of the inserter hole in the head of the screw.The complaint was confirmed, but the root cause could not be established.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device or inappropriate storage conditions.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging process found that each pouch is inspected for missing seals and defects.The presence of all seals is visually confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI-HA 9X30 STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13827319
• MDR Text Key: 287530537
• Report Number: 1219602-2022-00392
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 03596010460011
• UDI-Public: 03596010460011
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K002274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7207682
• Device Catalogue Number: 7207682
• Device Lot Number: 50972191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1