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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HNM STAINLESS, LLC DBA HNM MEDICAL HNM SUTURE PASSER DISPOSABLE NEEDLE NEEDLE, SUTURE, DISPOSABLE

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HNM STAINLESS, LLC DBA HNM MEDICAL HNM SUTURE PASSER DISPOSABLE NEEDLE NEEDLE, SUTURE, DISPOSABLE Back to Search Results
Model Number HNM-49-151385
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
Device was not returned for evaluation. Pictures sent by complainant confirms complaint - needle broken. Root cause unknown at this time. No delay or clinical complications.
 
Event Description
While doing procedure for repairing rotator cuff, physician on the last phase of passing the suture, the needle got jammed and broke. Doctor was able to retract the needle ( no part remained in patient and the patient did not suffered any harm). When inspecting the suture passer, the doctor retracted the needle and the distal end where the needle goes out was bent.
 
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Brand NameHNM SUTURE PASSER DISPOSABLE NEEDLE
Type of DeviceNEEDLE, SUTURE, DISPOSABLE
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 Key7934794
MDR Text Key123385643
Report Number3005031118-2018-00005
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2019
Device Model NumberHNM-49-151385
Device Catalogue Number26-30011
Device Lot Number2116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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