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

Catalog Number 4206000000

Device Problem Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2015

Event Type  malfunction  

Event Description

It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the handpiece was slow to stop after the trigger was released.There was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The device has not been received at the manufacturer for testing. an evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Manufacturer Narrative

Additional information: device not available for evaluation.

Event Description

It was reported during routine maintenance conducted by a manufacturer field service technician at the user facility that the handpiece was slow to stop after the trigger was released.There was no associated procedure.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: SYSTEM 5 RECIPROCATING 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: 4952639
• MDR Text Key: 6039388
• Report Number: 0001811755-2015-02772
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2017

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: 4206000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 07/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2005
• 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