MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 7 SAGITTAL SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number 7208000000

Device Problem Disassembly (1168)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/19/2016

Event Type  Injury  

Event Description

It was reported that during a surgical procedure at the user facility that the device spring, metal toggle and ball bearing fell off the device.The spring and the metal toggle were retrieved; however, the ball bearing was not able to be retrieved.The patient was stitched up and will be given an x-ray once out of recovery.Currently, the location of the ball bearing is not known.No additional information regarding the condition of the patient or the impact of the event has been provided at this time.Attempts are being made to retrieve this information.

Manufacturer Narrative

The user facility was contacted and refused to offer additional information regarding this event.No additional information is available regarding this event.

Event Description

It was reported that during a surgical procedure at the user facility that the device spring, metal toggle and ball bearing fell off the device.The spring and the metal toggle were retrieved; however, the ball bearing was not able to be retrieved.The patient was stitched up and will be given an x-ray once out of recovery.Currently, the location of the ball bearing is not known.No additional information regarding the condition of the patient or the impact of the event has been provided at this time.Attempts are being made to retrieve this information.

• Brand Name: SYSTEM 7 SAGITTAL SAW
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-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: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6254362
• MDR Text Key: 64883231
• Report Number: 0001811755-2017-00064
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7208000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other