MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL PIN DRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 71513331

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Patient Involvement (2645)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

It was reported that the pin driver is no longer holding pins securely due to wear and tear of use.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the entry point of the pin driver where the connection of the pin goes is severely damaged.The device shows significant signs of wear/usage.The device was manufactured in 2017.A functional evaluation confirmed the stated failure.The driver would not hold a.123 pin gage as intended.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: UNIVERSAL PIN DRIVER
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10408195
• MDR Text Key: 202948417
• Report Number: 1020279-2020-03924
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010589064
• UDI-Public: 03596010589064
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71513331
• Device Catalogue Number: 71513331
• Device Lot Number: 17JM09200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1