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

Model Number SN-5698G

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 03/22/2022

Event Type  Injury  

Event Description

According to the reporter, during the suturing of left ring finger, after the surgeon was able to place the 1st suture and tied off, and while the surgeon was placing the 2nd suture, the curved tip of the needle broke off in patient laceration.The other half was attached to the suture thread.This irrigated and explored a bloodless field, that was unable to retrieve.The patient had to go to emergency room for x-ray and removal.

Manufacturer Narrative

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

• 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: 14381749
• MDR Text Key: 291602780
• Report Number: 9612501-2022-00798
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10884521079151
• UDI-Public: 10884521079151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

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: SN-5698G
• Device Catalogue Number: SN-5698G
• Device Lot Number: D1H0726FY
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/12/2022
• Date Device Manufactured: 08/07/2021
• 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): Other