MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3IN 19G STRAIGHT DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT; ARTHROSCOPE

Catalog Number 0407281000

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/17/2018

Event Type  Injury  

Event Description

It was reported that during a procedure, the probe broke off inside of the patient.The procedure was not successfully completed as medical intervention was necessary to remove the device material.No additional adverse consequences were reported.

Manufacturer Narrative

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

Event Description

It was reported that during a procedure, the probe broke off inside of the patient.The procedure was not successfully completed as medical intervention was necessary to remove the device material.No additional adverse consequences were reported.

• Brand Name: 3IN 19G STRAIGHT DEKOMPRESSOR PERCUTANEOUS DISCECTOMY KIT
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 00615
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 8071656
• MDR Text Key: 127200329
• Report Number: 0001811755-2018-02468
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04546540500229
• UDI-Public: 04546540500229
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032473
• 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
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0407281000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/14/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1