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

Model Number	N-2512
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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
• Report Number: 9612501-2021-02070
• Device Sequence Number: 12238821
• Product Code: GAR
• UDI-Device Identifier: 10884521075931
• UDI-Public: 10884521075931
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: N-2512
• Device Catalogue Number: N-2512
• Device Lot Number: D1D0691Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 12/13/2021
• Date Device Manufactured: 04/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male