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

Model Number	88862393-69
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2018
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 a coronary artery bypass grafting procedure, the needle was becoming crooked while in the process, it could not be passed from the bone, and it was not enough for the closure of the sternum.They used another device to complete the case.It was also reported that the incision was extended by more than 1 inch.
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 procedure, the needle was becoming crooked while in the process, it could not be passed from the bone, and it was not enough for the closure of the sternum.They used another device to complete the case.There was no patient injury.

• 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: 8189181
• Report Number: 9612501-2018-02263
• Device Sequence Number: 19308134
• Product Code: GAQ
• UDI-Device Identifier: 10884521102477
• UDI-Public: 10884521102477
• 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,Followup
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 88862393-69
• Device Catalogue Number: 88862393-69
• Device Lot Number: D7K0725X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention