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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/26/2016

Event Type  malfunction  

Event Description

During a total joint procedure, a system 5 drill was used with 6 batteries during the case- none of the batteries held charge, although they were charged and sterilized per parameters.Another system 5 drill was offered to see if it was the drill or the batteries, but the surgeon deferred to continue to work with present drill as he was almost complete with his surgical cuts.After the procedures, the drills were tested and neither drill seemed to have audible torque, although torque is difficult to assess unless being used on patient.The company rep was contacted to assess the quarantined drills for further evaluation.All batteries have been recharged to their limit.

• Brand Name: SYSTEM 5 DRILL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS; 4100 east milham ave.; kalamazoo MI 49001
• MDR Report Key: 5959555
• MDR Text Key: 55023395
• Report Number: 5959555
• Device Sequence Number: 1
• Product Code: KIJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2016

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: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR