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

Catalog Number 4208000000

Device Problem Disassembly (1168)

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

Event Date 03/14/2014

Event Type  malfunction  

Event Description

It was reported that prior to a surgical procedure at the user facility a piece from the head of the device disassembled.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Event Description

It was reported that prior to a surgical procedure at the user facility a piece from the head of the device disassembled.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

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.

Manufacturer Narrative

The reported disassembly of the device was confirmed by a manufacturer repair technician through visual inspection.Potential causes for the reported disassembly include the decorative screw becoming loose due to vibration and falling off on impact.

• Brand Name: 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: 3747520
• MDR Text Key: 4464703
• Report Number: 0001811755-2014-01298
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4208000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2002
• 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