MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL 3.5MM HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71751140

Device Problems Connection Problem (2900); Naturally Worn (2988)

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

Event Date 04/05/2021

Event Type  malfunction  

Event Description

It was reported that a humeral 3.5mm hexdriver had an unspecified failure.Since it was noticed during a field inspection, no patient was involved.After investigation it was noticed that the device was paired with the mating part mechanism and does not function as intended.

Manufacturer Narrative

H3, h6: the associated device, intended for use in treatment, was returned and evaluated.A visual inspection of the returned device has nicks and scratches on the device.The device shows signs of extensive use.A functional evaluation confirmed that the device was paired with mating part mechanism and does not function as intended.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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 the 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.We consider this investigation closed.

• Brand Name: HUMERAL 3.5MM HEXDRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11995898
• MDR Text Key: 256238212
• Report Number: 1020279-2021-05161
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010515483
• UDI-Public: 03596010515483
• 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
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

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: 71751140
• Device Catalogue Number: 71751140
• Device Lot Number: 18GM19782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1