MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD STEEL; SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Model Number	88862424-89
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2020
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 a coronary artery bypass grafting, while trying to combine the ribs while using a continuous suturing technique, the needle of the device broke.Another package was opened and the 2 of the needle in the package also broke.Another device was used to resolve the issue.No patient harm.

• Brand Name: STEEL
• Common Device Name: SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 9673520
• Report Number: 9612501-2020-00221
• Device Sequence Number: 353926
• Product Code: GAQ
• UDI-Device Identifier: 10884521102699
• UDI-Public: 10884521102699
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K955723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: 05/31/2024
• Device Model Number: 88862424-89
• Device Catalogue Number: 88862424-89
• Device Lot Number: D9F0929Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1