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

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure, the blade broke in two pieces.No further information was provided.

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text: device not available for return.

Event 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)
• Type of Device: 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
• MDR Text Key: 295983827
• Report Number: 3015967359-2022-01206
• Device Sequence Number: 1
• Product Code: DWH
• UDI-Device Identifier: 04546540895042
• UDI-Public: 04546540895042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1