MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STERNUM BLADE, OFFSET (31.5 X 0.64 X 6.2MM); BLADE, SAW, SURGICAL, CARDIOVASCULAR

Model Number	0296097102
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, the blade broke in two pieces.No further information was provided.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text: device not available for return.
Event or Problem Description
It was reported that during a surgical procedure, the blade broke in two pieces.No further information was provided.

• Brand Name: STERNUM BLADE, OFFSET (31.5 X 0.64 X 6.2MM)
• 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: 14801515
• Report Number: 3015967359-2022-01206
• Device Sequence Number: 17315961
• Product Code: DWH
• UDI-Device Identifier: 04546540895042
• UDI-Public: 04546540895042
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0296097102
• Device Catalogue Number: 0296097102
• Device Lot Number: 22070017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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
• Patient Sex: Unknown