MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORPORATION LTD SPEEDSNARE SURGICAL SUTURE PASSER 30 DEG RIGHT; SPEEDSNARE¿ SURGICAL SUTURE PASSER 30 DEG RIGHT

Model Number 253001BSM

Device Problems Bent (1059); Break (1069); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

When the surgeon was trying to go through the soft tissue (labrum) with the device it bent and broke for the distal part.Front his point of view, this part of the passer is too much soft and in this kind of pathologies you need to push or strain to go through the labrum and sometimes brush against the glenoid, and for that reason it´s very important a strong stem.Furthermore, the plastic handle has also a wrong design.When you try to turn it in order to pass the system across the soft tissue, it turn around independently to the steel stem.And doesn't work.After that, the surgeon used an ideal suture passer from depuy mitek and everything went well.

• Brand Name: SPEEDSNARE SURGICAL SUTURE PASSER 30 DEG RIGHT
• Type of Device: SPEEDSNARE¿ SURGICAL SUTURE PASSER 30 DEG RIGHT
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• Manufacturer (Section G): T.A.G. MEDICAL PRODUCTS CORPORATION LTD; kibutz gaaton; gaaton, 25130 000; IS 25130000
• Manufacturer Contact: shlomi dines ; gaaton; gaaton, 25130-00 ; IS 2513000
• MDR Report Key: 7208775
• MDR Text Key: 98186898
• Report Number: 8043971-2018-00003
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/30/2021
• Device Model Number: 253001BSM
• Device Catalogue Number: 253001BSM
• Device Lot Number: 17J20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1