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

Model Number	GS-63-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	03/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reported.There were 6 needles in 1 pack.(it must be 5 needle per 1 pack).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual analysis of the returned product noted six suture-needles instead of five.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 is an operator error.The incorrect count condition can be generated if an incorrect quantity of suture-needles is placed in the carousel and if this is not correctly verified in the next operation.The incorrect count condition could have originated if the winding operator took one extra unit and did not correctly verify the quantity of units in the retainer.The product analysis established a relationship between a device failure and the reported incident of incorrect needle quantity.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process improvement and retraining has been implemented to prevent this condition from recurring.A corrective action has also been implemented for this condition.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.

• 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: 6969887
• Report Number: 9612501-2017-06470
• Device Sequence Number: 1068462
• Product Code: GAP
• UDI-Device Identifier: 10884521085077
• UDI-Public: 10884521085077
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2018

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 Model Number: GS-63-M
• Device Catalogue Number: GS-63-M
• Device Lot Number: D6D3111X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: 02/06/2018; 02/22/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 02/20/2018; 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1