MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LOANER SYSTEM 5 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4208000000L

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

It was reported that during testing conducted at the manufacturer facility the trigger of the device was reversed, which could result in the inability to place the device into safe mode.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.

Event Description

It was reported that during testing conducted at the manufacturer facility, the trigger of the device was reversed, which could result in the inability to place the device into safe mode.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.

Manufacturer Narrative

The reported event was confirmed by a manufacturer repair technician through visual inspection.Signs of third party work on the internal components of the device were noted during failure analysis.Unauthorized modification of these components is a potential cause of the reported event.The device instructions for use states that no service should be attempted on the device system components and that all concerns should be directed to stryker service.Stryker recommends that all failures and maintenance associated with its devices should be directed to trained stryker service professionals.The device was repaired and returned to the manufacturer loaner pool.

• Brand Name: LOANER SYSTEM 5 SAGITTAL SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 4156166
• MDR Text Key: 4769636
• Report Number: 0001811755-2014-03542
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972367
• 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: 09/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4208000000L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2006
• 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