MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	GS-67-M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an open exploratory laparotomy, while at bowel resection, the needle of the two products broke at the tip.The surgeon was grabbing the very tip when performing the pop off while suturing the bowel.The surgeon did not continue the procedure using the same product.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• 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: 14272809
• Report Number: 9612501-2022-00710
• Device Sequence Number: 4893023
• Product Code: GAP
• UDI-Device Identifier: 10884521085121
• UDI-Public: 10884521085121
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Model Number: GS-67-M
• Device Catalogue Number: GS-67-M
• Device Lot Number: D1J2653Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/04/2022
• Date Device Manufactured: 09/27/2021
• 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
• Patient Sex: Male