MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1/4 INCH REAMER WITH JACOBS CHUCK; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 4100231000

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that during device evaluation conducted by a manufacturer field service technician at the user facility determined that the attachment was falling from the device.No patient involvement, no clinically significant delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Evaluation conclusion: the device was scrapped by the manufacturer.

• Brand Name: 1/4 INCH REAMER WITH JACOBS CHUCK
• 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: 4134981
• MDR Text Key: 4942985
• Report Number: 0001811755-2014-03460
• Device Sequence Number: 1
• Product Code: KIJ
• 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
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4100231000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2009
• 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