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

Catalog Number 4100400000

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/28/2015

Event Type  Injury  

Event Description

It was reported that during a surgical procedure at the user facility that the device had metal shavings coming out of it and the ball bearings came out, as well.The patient required an x-ray to locate a missing ball bearing while still on the operating table.The missing ball bearing was identified in the patient's toe and was cut out.This resulted in a delay of less than 10 minutes.No additional adverse consequences were reported and the procedure was completed successfully.

Event Description

It was reported that during a surgical procedure at the user facility that the device had metal shavings coming out of it and the ball bearings came out, as well.The patient required an x-ray to locate a missing ball bearing while still on the operating table.The missing ball bearing was identified in the patient's toe and was cut out.This resulted in a delay of less than 10 minutes.No additional adverse consequences were reported and the procedure was completed successfully.

• Brand Name: SAGITTAL SAW ATTACHMENT
• 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: 5174189
• MDR Text Key: 29165491
• Report Number: 0001811755-2015-03895
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943323
• 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: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4100400000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2007
• 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
• Patient Outcome(s): Required Intervention