MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 DEPTH GAUGE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number 71364451

Device Problem Material Separation (1562)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2020

Event Type  Injury  

Event Description

It was reported that during surgery, the r3 depth gauge snapped into two pieces while the surgeon was using it.Both pieces were recovered and nothing was left in the patient.Procedure concluded with the same device.No delay or injury reported.

Manufacturer Narrative

H3, h6: the affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed and complaint could not be confirmed.The clinical/medical investigation concluded that per complaint details, the device broke during use; however, "both pieces were recovered, and nothing was left in the patient".Since the procedure concluded with the same device and no surgical delay or patient jury was reported, no further medical assessment is warranted at this time.Should clinically relevant documentation/information become available, the clinical/medical task may be re-evaluated.A review of complaint history did not 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.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.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: R3 DEPTH GAUGE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10381217
• MDR Text Key: 202108976
• Report Number: 1020279-2020-03785
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 03596010599438
• UDI-Public: 03596010599438
• Combination Product (y/n): N
• PMA/PMN Number: K093047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71364451
• Device Catalogue Number: 71364451
• Device Lot Number: 13BM10802
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention