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

Catalog Number 4107008000

Device Problem Disassembly (1168)

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

Event Date 12/18/2015

Event Type  malfunction  

Event Description

It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of thad blade guard.The customer was concerned if the metal pieces remain in a patient and the potential to cause damage.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of the blade guard.The customer was concerned if the metal pieces remain in a patient and the potential to cause damage.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported event, there is advanced wear on the distal tip of the blade guard, was not confirmed.However, the reported event of metal pieces came off of the device, was confirmed.The technician observed damage to the tip of the device and a small amount of material was missing.Further visual inspection revealed that the leg was bent and damaged.Based on a review of risk documentation and age of the device, improper use including using excessive lateral force during operation can cause or contribute to the reported event.

Event Description

It was reported during product inspection at the user facility, the customer observed that several pieces of metal were removed from the tip of the blade guard.The customer was concerned if the metal pieces remain in a patient and the potential to cause damage.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: STERNUM BLADE GUARD
• 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: 5366310
• MDR Text Key: 35971300
• Report Number: 0001811755-2016-00054
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4107008000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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