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

Model Number	88862392-49
Medical Device Problem Codes	Dull, Blunt (2407); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	07/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the needle did not penetrate the sternum and the needle detached.A medical intervention was needed or prevent permanent impairment.It was stated that the event resulted to unanticipated tissue loss and tissue damage.

• 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: 9088661
• Report Number: 9612501-2019-01781
• Device Sequence Number: 16848977
• Product Code: GAQ
• UDI-Device Identifier: 10884521102453
• UDI-Public: 10884521102453
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K955723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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 Model Number: 88862392-49
• Device Catalogue Number: 88862392-49
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/19/2019
• 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
• Patient Age: 56 YR
• Patient Weight: 85