MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD STEEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Model Number 88862414-89

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operatively, the wire was not cutting well through sternum and was blunt.It was stated that it was difficult and dull to drive through tissue.It was required to push the needle through.The product was changed.It was stated that surgical time was extended to 30 minutes or more due to the device's issue.There was no patient injury.

• Brand Name: STEEL
• Type of Device: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 11766664
• MDR Text Key: 248814416
• Report Number: 9612501-2021-00697
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10884521102620
• UDI-Public: 10884521102620
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K955723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 88862414-89
• Device Catalogue Number: 88862414-89
• Device Lot Number: D9H2104Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2021
• Date Device Manufactured: 08/27/2019
• 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