MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SAFEDGE SAFEDGE 2108 SAGITTAL BLADE STERNUM REVISION; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	2108125000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/27/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that during "opening of the sternum, intraoperatively, it was reported that the saw had failed, which caused myocardial injury".Further details provided stated that this was an elective procedure for atrioventricular septum correction.The blade being used was not reported to have malfunctioned.It was further reported that during the incision in the sternum, the saw went beyond the bone limits and reached structures of the myocardial muscles.The patient died following this procedure.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.

• Brand Name: SAFEDGE SAFEDGE 2108 SAGITTAL BLADE STERNUM REVISION
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18967201
• Report Number: 3015967359-2024-00551
• Device Sequence Number: 6807381
• Product Code: GFA
• UDI-Device Identifier: 04546540042088
• UDI-Public: 04546540042088
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2108125000
• Device Lot Number: 23137017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7208000000 SYSTEM 7 SAGITTAL SAW; 7215000000 STRYKER SMARTLIFE BATTERY PACK, LARGE
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Weight: 10 KG