MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TEARDROP HANDLE WITH LARGE AO; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71177131

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Event Description

It was reported that, after a trauma surgery, a 4.7mm ball hexdriver was stuck inside teardrop handle with large ao.The procedure was successfully completed without delay using a smith and nephew back up device.Patient was not harmed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.This device is a reusable instrument that can be exposed to numerous surgeries.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, 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.We consider this investigation closed.

• Brand Name: TEARDROP HANDLE WITH LARGE AO
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11822168
• MDR Text Key: 250613256
• Report Number: 1020279-2021-04280
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010601506
• UDI-Public: 03596010601506
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• 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: 07/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 71177131
• Device Catalogue Number: 71177131
• Device Lot Number: 17DAB0014
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1