MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE RATCHET DRIVER; ACCESSORIES,ARTHROSCOPIC

Model Number 72201888

Device Problem Break (1069)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during surgery using a biosure ratchet driver, it was noticed that the product key was broken.The procedure was completed without delay, but it is unknown how.No further complications were reported.

Manufacturer Narrative

H3, h6: ¿the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.It was determined the device did not contribute to the reported event.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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 customer provided image found a picture of the distal end of the device.The tip of the device is broken.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.¿ corrected data: b5: event description h1: type of reportable event h6: health effect - impact code.

Event Description

It was reported that, during surgery using a biosure ratchet driver, it was noticed that the product key was broken.It is unknown how the procedure was completed.No delay and no further complications were reported.

• Brand Name: BIOSURE RATCHET DRIVER
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: 13120340
• MDR Text Key: 283084287
• Report Number: 1219602-2021-02813
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010615442
• UDI-Public: 03596010615442
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 72201888
• Device Catalogue Number: 72201888
• Device Lot Number: 50563816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 02/15/2022
• Date Device Manufactured: 09/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention