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

Model Number	GS-46-M
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)
Date of Event	04/03/2018
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 exploratory laparotomy procedure, while the bowel was being sutured for anastomosis, the needle broke and a piece could not be found.Two needle broke, both from the same box but not the same pack.All pieces were located to one needle.The other still had a missing piece.More suture was opened to resolve the issue and complete the case.An x- ray was used however they needed to use it as part of the procedure not just to look for the needle.The needle was not located.There was no reported patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.The visual inspection of the returned photo noted several needles, however the image was blurry and pmv was unable to confirm that any of the needles were broken.Unfortunately, because no products were returned, functional testing could not be performed.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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 ; DO 0101
• MDR Report Key: 7441434
• Report Number: 9612501-2018-00783
• Device Sequence Number: 1147186
• Product Code: GAP
• UDI-Device Identifier: 20884521085012
• UDI-Public: 20884521085012
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2018

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: 09/30/2022
• Device Model Number: GS-46-M
• Device Catalogue Number: GS-46-M
• Device Lot Number: D7J1321X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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