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

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.

• Brand Name: HNM SUTURE PASSER DISPOSABLE NEEDLE
• Type of Device: NEEDLE, 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 Key: 7871354
• MDR Text Key: 120262988
• Report Number: 3005031118-2018-00004
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2019
• Device Model Number: HNM-49-151385
• Device Catalogue Number: 26-30011
• Device Lot Number: 2116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1