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

Model Number	88862226-69
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2018
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, at the time of closure during the exploratory sternotomy, the needle used appeared fragile from the first transosseous passage.The sutured dulled and twisted until it became straight and disengaged from the steel wire.In addition, steel wire was difficult to tighten at the bone edges because it broke.A foreign body was in the surgical site.The surgical time was extended to 30 minutes or more and incision was extended to more than 1 inch.The extension of the surgical time weakened the sternal bone.

• 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: 8609478
• Report Number: 9612501-2019-00964
• Device Sequence Number: 13953109
• Product Code: GAQ
• UDI-Device Identifier: 20884521102382
• UDI-Public: 20884521102382
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 07/31/2022
• Device Model Number: 88862226-69
• Device Catalogue Number: 88862226-69
• Device Lot Number: D7G0021X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 05/14/2019
• 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: 58 YR