MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTHESIS HIP SMI-CONSTRAINED METALCRAMICPOLYMR CEMNTED OR NON-POROUS UNCEMNTED

Catalog Number 71365705

Device Problem Break (1069)

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

Event Date 11/06/2018

Event Type  malfunction  

Event Description

It was reported that during surgery.The threaded tip of this inserter broke off while impacting the stem.0-30 min delay, had back up, no injury, no pieces left in the patient.

Manufacturer Narrative

The affected anthology posterior hard stem inserters were returned and evaluated.An inspection of the products confirmed the stated failure.From the analysis conducted during this investigation, it was concluded that the devices fractured at the threaded tip, most likely from impact.The broken pieces were not returned.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 occurring while the inserter is not fully captured in the driver hole platform of the stem.This fracture caused the instrument to become inoperable.The devices were manufactured in 2014 and 2016 and they show signs of significant use and wear.Our investigation included a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: PROSTHESIS HIP SMI-CONSTRAINED METALCRAMICPOLYMR CEMNTED OR NON-POROUS UNCEMNTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8203914
• MDR Text Key: 131642114
• Report Number: 1020279-2018-02934
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71365705
• Device Lot Number: 16DSA0014A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1