MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NAV PIN 3MM X 100MM CASE OF 10; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 6007003100

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device was discarded by the customer.

Event Description

It was reported that a patient experienced a fracture of the tibia on (b)(6) 2019, in the area where total knee procedure had been performed on (b)(6) 2019.The fracture was addressed by an osteosynthesis procedure.

Manufacturer Narrative

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

Event Description

It was reported that a patient experienced a fracture of the tibia on (b)(6) 2019, in the area where total knee procedure had been performed on (b)(6) 2019.The fracture was addressed by an osteosynthesis procedure.

• Brand Name: NAV PIN 3MM X 100MM CASE OF 10
• Type of Device: NEUROLOGICAL 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: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8741247
• MDR Text Key: 149411201
• Report Number: 0001811755-2019-02143
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6007003100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2019
• 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: Initial
• Patient Sequence Number: 1