MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2108 SERIES SAGITTAL BLADE, NO OFFSET (12.4 X 1.27 X 82.1MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number 2108158000

Device Problem Fracture (1260)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported that after a tka procedure, the blade was observed to be broke at the mount.It was also reported that there were no adverse consequences, no medical intervention and no delays as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that after a tka procedure, the blade was observed to be broke at the mount.It was also reported that there were no adverse consequences, no medical intervention and no delays as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

This event was originally reported as part of the voluntary malfunction summary report (vmsr) program under mfr report # 3015967359-2023-00792, submitted on 24 april 2023.This record, mfr report # 3015967359-2023-01146, was filed in error.

• Brand Name: 2108 SERIES SAGITTAL BLADE, NO OFFSET (12.4 X 1.27 X 82.1MM)
• 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: 16962745
• MDR Text Key: 315660475
• Report Number: 3015967359-2023-01146
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540042200
• UDI-Public: 04546540042200
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2108158000
• Device Catalogue Number: 2108158000
• Device Lot Number: 22346027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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