MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SABO SAGITTAL SAW; ARTHROSCOPE

Catalog Number 4300034000

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 08/17/2016

Event Type  malfunction  

Event Description

It was reported that during routine testing, conducted by a manufacturer field service technician at the user facility, the run/safe switch on the handswitch does not lock into safe mode, presenting a potential for the device to inadvertently be activated.As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

Manufacturer Narrative

The service technician evaluated the device and confirmed the handpiece does not go into safe mode.The trigger would not rotate and the device had wide spread corrosion.Parts were replaced and the device was programmed.

Event Description

It was reported that during routine testing, conducted by a manufacturer field service technician at the user facility, the run/safe switch on the handswitch does not lock into safe mode, presenting a potential for the device to inadvertently be activated.As this event occurred during testing at the user facility, there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SABO SAGITTAL SAW
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5945098
• MDR Text Key: 54514433
• Report Number: 0001811755-2016-02180
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943323
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4300034000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1