MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POSTER HARD; PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE

Catalog Number 71365705

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

It was reported that during surgery the inserter tip broke off in stem while impacting the implant.No delay nor injury reported.A s&n backup was available.No pieces fell inside the patient, but the broken tip was left inside the stem.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The tip of the threaded end of the device fractured off and was not returned.The device was manufactured in 2008 and exhibits signs of extensive wear / usage.This failure likely occurred from impact.An impact fracture can occur if the mechanical loads applied to the instrument exceed the strength of the material.The medical investigation concluded that, based solely on the product evaluation, the root cause of the inserter tip breakage was due to age related wear.It is unclear if the ifu were adhered to; however, it was noted in the ifu as a potential complication.The inserter tip is comprised of a non-implantable alloy and it recommends no patient contact or only short-term contact with tissue and/ or bone for less than 24 hours.Since it was indicated the inserter tip remained inside the stem, which was embedded in the bone, migration/micromotion is unlikely.The patient impact beyond the local irritation/discomfort and probable mri restrictions cannot be determined.No further medical assessment is warranted at this time.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 have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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: ANTHOLOGY INSERTER POSTER HARD
• Type of Device: PROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATE
• 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: 9318667
• MDR Text Key: 166824846
• Report Number: 1020279-2019-04025
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03596010555663
• UDI-Public: 03596010555663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113789
• 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: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• 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: 08AM12739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2019
• 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