MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SET SCREW DRIVER; SCREWDRIVER

Model Number 71665014

Device Problem Material Separation (1562)

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

Event Date 02/03/2021

Event Type  malfunction  

Event Description

It was reported that, the pin of a set screw driver that holds two pieces together, came out.It is unknown whether the event happened during surgery and if there was a patient involvement.

Manufacturer Narrative

The associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The returned device has disassembled at the pivot joint rendering the device inoperable.The device shows signs of extensive use.A review of complaint history did not reveal additional complaints for the listed item.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 do not have 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.Should 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.Internal complaint reference number: (b)(4).

Event Description

It was reported that, the pin of a set screw driver that holds two pieces together, came out.It was discovered in between cases; therefore, there was no patient involvement and no delay.No other complications were reported.

• Brand Name: SET SCREW DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11403055
• MDR Text Key: 234391816
• Report Number: 1020279-2021-01768
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 03596010518989
• UDI-Public: 03596010518989
• 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: 04/08/2021

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: 71665014
• Device Catalogue Number: 71665014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1