MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STERNUM BLADE (100PK) OFFSET (32.0 X 0.79 X 6.3MM); BLADE, SAW, SURGICAL, CARDIOVASCULAR

Catalog Number	0298097104
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse event problem: the quality investigation is complete.Device not available for return.
Event or Problem Description
It was reported that during a procedure, the blade broke off in the sternum bone.The procedure was stopped, the patient¿s lungs were re-inflated, the product was removed, and a new product was obtained to finish procedure.The procedure was completed successfully; the duration of the surgical delay was not reported, and no additional adverse consequences were reported.

• Brand Name: STERNUM BLADE (100PK) OFFSET (32.0 X 0.79 X 6.3MM)
• Common Device Name: BLADE, SAW, SURGICAL, CARDIOVASCULAR
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16156762
• Report Number: 3015967359-2023-00054
• Device Sequence Number: 7005169
• Product Code: DWH
• UDI-Device Identifier: 34546540897924
• UDI-Public: 34546540897924
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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 Catalogue Number: 0298097104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 01/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown