MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	SN-763
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/02/2018
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, during an open procedure, when doing an intradermal suture, the thread came off the needle.A medical or surgical intervention was needed to prevent impairment of a function and there was a temporary injury to the patient.It was reported that they changed the suture and restarted from the beginning without any issue and more frequent dressing change was done.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned samples noted one suture and one needle.The needle was noted to be detached from the suture.The needle was observed to be damaged at the swaged end.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all manufacturers¿ quality release specifications at the time of manufacture.The observed instrumentation damages suggested that the needles were 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: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7286803
• Report Number: 9612501-2018-00233
• Device Sequence Number: 19161760
• Product Code: GAR
• UDI-Device Identifier: 20884521080178
• UDI-Public: 20884521080178
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 02/28/2022
• Device Model Number: SN-763
• Device Catalogue Number: SN-763
• Device Lot Number: D7B1310FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1