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

Model Number	SN-5666G
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
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 finger amputation, the suture broke while wrapping around needle driver to tie.The incident occurred at the end of the procedure.The case was finished on last stitch.There was no patient injury.
Additional Manufacturer Narrative
Correction: this report 9612501-2018-01283 was sent in error as a duplicate for mfr report number: 9612501-2018-01267, any additional information received in the future will be captured and submitted under the report number 9612501-2018-01267.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: 7681620
• Report Number: 9612501-2018-01283
• Device Sequence Number: 11017607
• Product Code: GAR
• UDI-Device Identifier: 20884521078779
• UDI-Public: 20884521078779
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 10/31/2022
• Device Model Number: SN-5666G
• Device Catalogue Number: SN-5666G
• Device Lot Number: D7K0050X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 64