MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DEPTH GAUGE FOR 2.0MM SCREWS; PLATE, FIXATION, BONE

Model Number 71174922

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/28/2020

Event Type  malfunction  

Event Description

It was reported that during the procedure, the numerical letters on the depth gauge were not current, and furthermore, the dashed lines did not differ in length to facilitate reading.This occurred inside the patient.The procedure was completed without delay and it was finish with the same device.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information received states that the etch marks on the instrument are legible and correct and the complaint was to inform that these seem lighter than the new instruments received at the user facility.It was reported that there was no patient harm or medical intervention.Based on this new information, it was determined that this event does not meet the threshold for reporting.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and the investigation performed.

Event Description

Physician reported that during an unknown surgical procedure, the etch marks on the depth gauge seemed to be less dark compared with the newer ones received.This condition was noted in the instruments currently in use by the customer after repeated uses.The reporter confirmed that the marks are legible and correct and the procedure was completed with the same device without any delay and there was no patient impact reported.Physician also mentioned that the marks could be made so that they differ in length to improve usability of the device in future designs.

• Brand Name: DEPTH GAUGE FOR 2.0MM SCREWS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10432876
• MDR Text Key: 203725422
• Report Number: 1020279-2020-04091
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556387399
• UDI-Public: 00885556387399
• Combination Product (y/n): N
• PMA/PMN Number: K132886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71174922
• Device Catalogue Number: 71174922
• Device Lot Number: 14LTRS138
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1