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

Model Number	SN-5698G
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 14381749
• Report Number: 9612501-2022-00798
• Device Sequence Number: 17823705
• Product Code: GAR
• UDI-Device Identifier: 10884521079151
• UDI-Public: 10884521079151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: SN-5698G
• Device Catalogue Number: SN-5698G
• Device Lot Number: D1H0726FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/12/2022
• Date Device Manufactured: 08/07/2021
• 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: Other
• Patient Sex: Unknown