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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 Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The needles (2) broke during suturing of a rotator cuff. No delay or clinical complications. Suspect devices have not been returned yet.
 
Event Description
During a suture process of a rotator cuff reconstruction, 2 disposable needle broke during the same procedure.
 
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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 Key7871354
MDR Text Key120262988
Report Number3005031118-2018-00004
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 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2018
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 Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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