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

Model Number	GS-67-M
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During trauma surgery, the device has incorrect count on the box.There were 6 needles present in the box instead of 5 needles only.It was passed on the sterile field but not used.No patient injury has been noted.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned samples noted six needles and six sutures in a retainer instead of five.The label on the foil stated that there are supposed to be five sutures and five needles.The six sutures were each attached to a needle.Samples were sent to engineering for further evaluation of the incorrect quantity of needles.Engineering concluded that this issue is an assembly problem and a corrective action has been implemented to prevent this condition from recurring.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.The root cause of the observed condition of incorrect quantity of needles was assigned to manpower.The manufacturing operator inadvertently took one extra unit prior to winding the units into the retainer.The product analysis established a relationship between a device failure and the reported incident of incorrect quantity of needles.The root cause of the observed condition was determined to be a result of a manufacturing error and a process improvement has been implemented to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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 ; DO 0101
• MDR Report Key: 6818694
• Report Number: 9612501-2017-06017
• Device Sequence Number: 16175890
• Product Code: GAP
• UDI-Device Identifier: 10884521085121
• UDI-Public: 10884521085121
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2018

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: 08/31/2017
• Device Model Number: GS-67-M
• Device Catalogue Number: GS-67-M
• Device Lot Number: D2H0956GX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Initial Date Received by Manufacturer: 07/25/2017
• Supplement Date Received by Manufacturer: 02/06/2018; 03/02/2018
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 02/20/2018; 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1