MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. INSERTION HANDLE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number 00584305400

Device Problem Insufficient Information (3190)

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

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

The associated complaint device was returned and evaluated.Our assessment confirmed the insertion handle is stripped.The device shows significant signs of wear/usage.A review of complaint history for the part revealed no prior complaints for the listed batch.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

Event Description

It was reported that device was found stripped during surgery.Surgery was completed without the usage of the device and there was no backup available.However, no patient injury was involved and there was no delay to the surgery.

• Brand Name: INSERTION HANDLE
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0110148276
• MDR Report Key: 7874407
• MDR Text Key: 120245596
• Report Number: 1020279-2018-01821
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00885556621677
• UDI-Public: 00885556621677
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00584305400
• Device Lot Number: 62656522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization