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

Model Number	SS-694
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, after the device was applied for closure of the skin, the device¿s needle came off from the suture, and caused laceration to the patient¿s skin.In order to complete the case, the needle was removed from the skin.Patient has no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the returned samples noted two sutures and two needles.One of the needle was observed to be attached to a suture.The of the needle was broken at the swaged end.The swaged end of the needle was attached to a suture.It was observed, under magnification, that instrument marks were present on the swaged end of the needle.The retainer was inspected with no abnormalities.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.The observed instrumentation damages suggested that the needle was grasped improperly at the swaged end of the needle during application.Firmly grasping the needle at the swaged end can deform the crimp, can cause the needle to disengage from the suture, and can even cause the needle to break at the swaged end.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary 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: 7297807
• Report Number: 9612501-2018-00256
• Device Sequence Number: 19395430
• Product Code: GAP
• UDI-Device Identifier: 20884521088303
• UDI-Public: 20884521088303
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2018

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: 07/31/2022
• Device Model Number: SS-694
• Device Catalogue Number: SS-694
• Device Lot Number: D7G1387FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR