MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNIVERSAL TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 6000-005-000

Device Problem Disassembly (1168)

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

Event Date 11/17/2017

Event Type  malfunction  

Event Description

It was reported by the account that the device was discovered broken into pieces.The device breaking could lead to loose parts falling into the surgical site or into the patient.No known patient involvement or procedural delays were reported with this event.

Manufacturer Narrative

Device evaluation: follow-up report submitted to document device evaluation results.

Event Description

It was reported by the account that the device was discovered broken into pieces.The device breaking could lead to loose parts falling into the surgical site or into the patient.No known patient involvement or procedural delays were reported with this event.

• Brand Name: UNIVERSAL TRACKER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: zachary baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7108667
• MDR Text Key: 94532308
• Report Number: 0001811755-2017-02446
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

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: Health Professional
• Device Catalogue Number: 6000-005-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 01/03/2018
• Supplement Dates FDA Received: 05/10/2018
• 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