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

Model Number	88862410-69
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Hemostasis (1895)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, at the end of the procedure for coronary bypass, the steel wires loosen when used to close the sternum.There was an extension of the intervention period and a difficulty of sternal closure.There was an additional hemostasis of the sternal wound.Another suture was used to complete the case.

• 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: 9182492
• Report Number: 9612501-2019-01958
• Device Sequence Number: 16786273
• Product Code: GAQ
• UDI-Device Identifier: 10884521102576
• UDI-Public: 10884521102576
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2019

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: 05/31/2024
• Device Model Number: 88862410-69
• Device Catalogue Number: 88862410-69
• Device Lot Number: D9F2768Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/11/2019
• 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: Other
• Patient Age: 73 YR