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

Catalog Number	71174928
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the depth gauge broke off and had to be extracted off the patient.No delay reported.No patient injuries reported.An s&n backup was available.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned depth gauge confirms the tip of the device is broken off.The broken tip no returned with the device.This device was manufactured in 2014.The device exhibits signs of significant wear/ usage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
Lot number added.

• Brand Name: DEPTH GAUGE FOR 2.4MM AND 2.7MM SCREWS
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9079870
• Report Number: 1020279-2019-03422
• Device Sequence Number: 2477374
• Product Code: HRS
• UDI-Device Identifier: 00885556387696
• UDI-Public: 00885556387696
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2019

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 Catalogue Number: 71174928
• Device Lot Number: 14KTRS124
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019; 08/26/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/31/2019; 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1