MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS; PLATE, FIXATION, BONE

Model Number	71174959
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection, 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.
Additional Manufacturer Narrative
H3, h6: 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: SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11376963
• Report Number: 1020279-2021-01590
• Device Sequence Number: 17079397
• Product Code: HRS
• UDI-Device Identifier: 00885556399545
• UDI-Public: 00885556399545
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K132886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71174959
• Device Catalogue Number: 71174959
• Device Lot Number: 15BTRS033
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1