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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a procedure the short depth gauge 2.4mm/2.7mm screws tip broke off.No harm or injury reported on patient.Procedure was finished with the same device.No delay reported.
Additional Manufacturer Narrative
The device, intended for use in treatment was returned for evaluation: a visual inspection of the returned device confirmed the stated failure mode.The tip of the device is fractured.The fractured pieces weren't returned.A review of complaint history did reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This case reports the screw tip broke off of the depth gauge after the procedure.Per complaint details, there was no patient injury or surgical delay, and the procedure was completed using the same device.Therefore, since no patient harm occurred, no further clinical assessment is warranted.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; 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: 10788262
• Report Number: 1020279-2020-06164
• Device Sequence Number: 11673803
• Product Code: HRS
• UDI-Device Identifier: 00885556399545
• UDI-Public: 00885556399545
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/12/2021

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 Expiration Date: 03/15/2024
• Device Model Number: 71174959
• Device Catalogue Number: 71174959
• Device Lot Number: 14KTRS128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1