MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DUAL CUT SAGITTAL BLADE (18X90X1.37MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number 4118137090

Device Problem Fracture (1260)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded by customer.

Event Description

It was reported that during a total knee surgery, the blade broke at the mount.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

E1: updated initial reporter.H6: the quality investigation is complete.H3 other text: device discarded.

Event Description

It was reported that during a total knee surgery, the blade broke at the mount.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: DUAL CUT SAGITTAL BLADE (18X90X1.37MM)
• Type of Device: 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 13056334
• MDR Text Key: 282604197
• Report Number: 3015967359-2021-02760
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540964304
• UDI-Public: 04546540964304
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 4118137090
• Device Catalogue Number: 4118137090
• Device Lot Number: 21079057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2021
• 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