MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number SN-5663

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the needle detached from the thread, and the needle was temporarily lost during an open orthopedic procedure.The needle into the patient's cavity and was retrieved with a needle driver.Another device was used to complete the case.There was no patient injury.

• Brand Name: MONOSOF
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: 11617370
• MDR Text Key: 243895580
• Report Number: 9612501-2021-00544
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10884521078253
• UDI-Public: 10884521078253
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2021

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 Model Number: SN-5663
• Device Catalogue Number: SN-5663
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/06/2021
• 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