MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PS HIGH FLEX IMPCTR HD 3-8; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71441554

Device Problem Break (1069)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 02/10/2020

Event Type  malfunction  

Event Description

It was reported that during surgery, hi-flex impactor head size 3-8 broke while impacting the ps poly.All pieces were recovered from the patient.There was no harm to the patient or staff.No significant delay in the procedure because s&n back up was available.

Manufacturer Narrative

Additional information: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured in half, rendering it inoperable.All pieces were returned.The device also had numerous nicks and gouges in the surface.The device was manufactured in 2006 and shows signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.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.

• Brand Name: GII PS HIGH FLEX IMPCTR HD 3-8
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 9774037
• MDR Text Key: 181540806
• Report Number: 1020279-2020-00747
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010497376
• UDI-Public: 03596010497376
• 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,Followup
• Report Date: 03/12/2020

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: 71441554
• Device Catalogue Number: 71441554
• Device Lot Number: 06HM20584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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