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

Model Number	GS-30-M
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	05/02/2019
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 a laparoscopic procedure, the needle, broken during detaching the suture and an x-ray was performed to confirm if all pieces were located.A new suture was used to complete the procedure.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the opened samples noted one needle.The needle was received broken at the tip and received separated from the rest of the needle.Upon microscopic inspection, instrument marks were observed near the break site.As no sealed samples were returned, a bend moment test could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.The needle should always be held in the middle where the diameter is greatest.Grasping the needle near the swaged end or the tip could cause bends or breaks, or damage the connection between the needle and suture.No further actions have been deemed necessary at this time.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 18750 ; DO 18750
• MDR Report Key: 8665386
• Report Number: 9612501-2019-01064
• Device Sequence Number: 2103209
• Product Code: GAP
• UDI-Device Identifier: 20884521084848
• UDI-Public: 20884521084848
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 11/30/2022
• Device Model Number: GS-30-M
• Device Catalogue Number: GS-30-M
• Device Lot Number: D7L2094X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention