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

Model Number	71174922
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10432876
• Report Number: 1020279-2020-04091
• Device Sequence Number: 2259414
• Product Code: HRS
• UDI-Device Identifier: 00885556387399
• UDI-Public: 00885556387399
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

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