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

Model Number	88861927-32
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2017
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 craniotomy procedure, the two device's needles was broke while suturing on the dura and fell into patient cavity.The tip of needle was found by the surgeon.No patient injury has been noted.

• Brand Name: SURGILON
• 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: 7105933
• Report Number: 9612501-2017-06755
• Device Sequence Number: 1461167
• Product Code: GAR
• UDI-Device Identifier: 20884521072043
• UDI-Public: 20884521072043
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K981582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

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: 03/31/2022
• Device Model Number: 88861927-32
• Device Catalogue Number: 88861927-32
• Device Lot Number: D7C1355X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1