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 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.

• 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: 7934794
• MDR Text Key: 123385643
• Report Number: 3005031118-2018-00005
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1