MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ANTHOLOGY INSERTER POST SOFT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71365706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nipple on the end of this stem inserter broke off while inserting the stem into the patient.Doctor was able to get it out.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The pilot tip was broken off the device and was not returned.The device was manufactured in 2006 and exhibits signs of significate wear/usage.From the analysis conducted during this investigation, it was concluded that the device 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 complaint history did not reveal additional complaints for the listed batch.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.We consider this investigation closed.

• Brand Name: ANTHOLOGY INSERTER POST SOFT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7924593
• Report Number: 1020279-2018-01966
• Device Sequence Number: 16540569
• Product Code: JDI
• UDI-Device Identifier: 03596010555670
• UDI-Public: 03596010555670
• Combination Product (Y/N): N
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71365706
• Device Lot Number: 06AM14964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other