MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER ANT SOFT; PROSTHSIS HIP SMI-CONSTRAINED MTALCERAMICPOLYMER CEMNTED OR NON-POROUS UNCEMNTED

Catalog Number 71365721

Device Problem Break (1069)

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

Event Date 12/04/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, the tip broke off of the impactor.No delay.Smith and nephew back up device available.No injury reported.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection of the returned that the anthology inserter fractured at the tip, most likely from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.A fracture can also be the result of multiple impacts.This fracture caused the instrument to become inoperable.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: ANTHOLOGY INSERTER ANT SOFT
• Type of Device: PROSTHSIS HIP SMI-CONSTRAINED MTALCERAMICPOLYMER CEMNTED OR NON-POROUS UNCEMNTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8200604
• MDR Text Key: 131544363
• Report Number: 1020279-2018-02916
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010553409
• UDI-Public: 03596010553409
• Combination Product (y/n): N
• PMA/PMN Number: K113789
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71365721
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1