MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MODIFIED JII TIBIA CUTTING BLOCK RIGHT; TEMPLATE

Catalog Number E0015575-2

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

Event Type  Injury  

Event Description

It was reported that during surgery (instrument inside the patient) the trocar pin got bound up in the pin hole.Trocar pin broke off in pin hole.The procedure was completed without delay with the same device.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, this complaint from the united states reports that a trocar pin broke off in the pin hole.Reportedly, the procedure was completed without delay with the same device.Smith and nephew has not received adequate materials (operative reports or x-rays) to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.The impact to the patient cannot be determined because it was not reported, whether the broken pin was retained.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from misuse or rough handling are likely probable causes of the reported event.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: MODIFIED JII TIBIA CUTTING BLOCK RIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10609921
• MDR Text Key: 209328275
• Report Number: 1020279-2020-04989
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 00885556701645
• UDI-Public: 885556701645
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 08/06/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: E0015575-2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention