MAUDE Adverse Event Report: HNM STAINLESS, LLC DBA HNM MEDICAL HNM MEDICAL KERRISON; SPURLING KERRISON RONGEUR

Model Number HNM-1-57-0554

Device Problem Mechanical Problem (1384)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

This event was not initially reported as there was no clinical complications.This customer complaint was re-evaluated in (b)(6) 2018 to see if the event were to reoccur could a serious injury occur.Since a malfunction of this type may result in either complications or a prolonged procedure, a decision was made to file this as an mdr.Investigation conclusion: this item is a delicate product with a thin footplate which is specifically designed for small bones in the cervical area.One of the important aspects of using this product is not to twist or pry the instrument while cutting the bone.Moreover product cannot be used on larger bones.Product was used unintendedly or the product fell on the floor or on steel table and the thin foot place got all the force of impact in that small area and as a result it cracked.The product is very durable for normal intended use against any pressure, stress and is very hard and difficult to break.But it is vulnerable to shock though - impact against a hard object.(b)(4).

Event Description

On (b)(6) 2016, hnm's (b)(6) representative reported a broken kerrison rongeur - catalog # 1-57-0554.Item was purchased on (b)(6) 2014.Event description: the tip broke off in the spinal canal during surgery.No clinical complications.No additional information available.

• Brand Name: HNM MEDICAL KERRISON
• Type of Device: SPURLING KERRISON RONGEUR
• Manufacturer (Section D): HNM STAINLESS, LLC DBA HNM MEDICAL; 20855 ne 16th ave suite c15; miami FL 33179
• Manufacturer (Section G): HNM STAINLESS, LLC DBA HNM MEDICAL; 20855 ne 16th ave suite c15; miami FL 33179
• Manufacturer Contact: dan sragovicz ; 20855 ne 16th ave suite c15; miami, FL 33179
• MDR Report Key: 7847000
• MDR Text Key: 119536782
• Report Number: 3005031118-2018-00003
• Device Sequence Number: 1
• Product Code: HTX
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HNM-1-57-0554
• Device Catalogue Number: 157-0554
• Device Lot Number: C3/13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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