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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that during inspection, was noticed that the graduation hashmarks on the depth gauge would not denote 2mm increments, making the depth difficult for surgeons to read.This is the old style depth gauge before these hashmarks were updated to show 2mm increments.Same device was used to complete the procedure and no delay or injury occurred due to this event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device graduation hashmarks are fading, rendering the device inoperable.The device shows signs of extensive use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• 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: 11376933
• MDR Text Key: 233439302
• Report Number: 1020279-2021-01572
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71174922
• Device Catalogue Number: 71174922
• Device Lot Number: 14LTRS139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1