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

Model Number N-2512

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/14/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during an amputated finger replantation procedure, while performing anastomosis of the arteries, nerves, and veins of the fingers, the needle and the suture broke on six devices.It was noted that the suture was too brittle.This resulted to a longer suture time, anastomosis time was too long as well and damage to the patient¿s blood vessels and epineurium which required strengthened patient monitoring and postoperative care.The surgeon replaced the sutures multiple times to complete the surgery.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12987696
• MDR Text Key: 282578454
• Report Number: 9612501-2021-02070
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10884521075931
• UDI-Public: 10884521075931
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N-2512
• Device Catalogue Number: N-2512
• Device Lot Number: D1D0691Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/13/2021
• Date Device Manufactured: 04/11/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male