MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO REMB ELECTRIC RECIPROCATING SAW; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 6400037000

Device Problems Unintended Power Up (1162); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2016

Event Type  malfunction  

Event Description

It was reported that during equipment testing conducted by a manufacturer field service technician at the user facility the device caused a bias current message to be displayed on the console, signaling a condition occurred in which the device has the potential to run without user activation.It was reported that during testing conducted at the manufacturer facility the device was running without user activation.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: REMB ELECTRIC RECIPROCATING SAW
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• 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: 5890006
• MDR Text Key: 52555169
• Report Number: 0001811755-2016-01922
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6400037000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Date Manufacturer Received: 07/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2012
• 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