MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SABO2 SAG SAW; INSTRUMENT, SURGICAL ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4408000000

Device Problem Unintended Power Up (1162)

Patient Problem No Patient Involvement (2645)

Event Date 08/23/2016

Event Type  malfunction  

Event Description

It was reported that during routine testing conducted by a manufacturer field service technician at the user facility the device had a power surge and ran faster than expected at a higher speed.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

It was determined that the e box required replacement as it was fluctuating.The device passed all final inspection activities and shipped back to the account.

Event Description

It was reported that during routine testing conducted by a manufacturer field service technician at the user facility, the device had a power surge and ran faster than expected at a higher speed.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: SABO2 SAG SAW
• Type of Device: INSTRUMENT, SURGICAL ORTHOPEDIC, AC-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: 5959323
• MDR Text Key: 54996793
• Report Number: 0001811755-2016-02271
• Device Sequence Number: 1
• Product Code: HWE
• 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: 08/23/2016

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: Other
• Device Catalogue Number: 4408000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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