MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HDL ASSY DRCTR ACL GDE.; ACCESSORIES,ARTHROSCOPIC

Model Number 7205517

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that the arrow on the acl handle has worn off and it is no longer legible; therefore, it is impossible to set the angle of the aimer accurately.The malfunction was found during set up and was solved with no delays or patient harm using a back up device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product batch/lot identification information was provided, thus a manufacturing record review could not be conducted.A complaint history review concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.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 evaluation will be reopened for investigation.

• Brand Name: HDL ASSY DRCTR ACL GDE.
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11026659
• MDR Text Key: 222039357
• Report Number: 1219602-2020-02065
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010373250
• UDI-Public: 03596010373250
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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
• Device Operator: Health Professional
• Device Model Number: 7205517
• Device Catalogue Number: 7205517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1