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

Model Number	SN-667G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2018
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 mohs skin cancer surgery, the thread broke.It was noted that they ran a few sutures from that batch that were breaking.There was no patient injury.
Event or Problem Description
According to the reporter, during mohs skin cancer surgery, 10 minutes into the procedure of facial skin incision repair, the thread broke.It was noted that they ran a few sutures from that batch that were breaking.It was reported that the surgeon employed a simple interrupted stitch.To resolve the issue, they opened a new suture pack with the same lot number but the 2nd suture also broke.Then they opened a 3rd suture with a different lot number and the suture did not break.There was no patient injury.
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 twelve devices.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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: 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: 8191155
• Report Number: 9612501-2018-02268
• Device Sequence Number: 2069727
• Product Code: GAR
• UDI-Device Identifier: 10884521079847
• UDI-Public: 10884521079847
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/04/2019

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: 04/30/2023
• Device Model Number: SN-667G
• Device Catalogue Number: SN-667G
• Device Lot Number: D8D0701FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 01/11/2019; 02/14/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/15/2019; 02/04/2019; 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR