MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ORTHOPAEDICS SAW; ORTHOPEDIC INSTRUMENT

Catalog Number UNK_JR

Device Problem Mechanical Jam (2983)

Patient Problems Injury (2348); Hip Fracture (2349)

Event Date 11/16/2011

Event Type  Injury  

Manufacturer Narrative

It was noted the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be proved in a supplemental report upon completion of the investigation.

Event Description

The legal dept.Reported that the patient underwent on (b)(6) 2011 to a surgical procedure of right hip arthroplasty with arthroplasty for osteoarthritis of the hip.During the surgery the orthopaedics saw was stuck and the osteotomy was completed with a hand chisel in the absence of an anther available saw.During this maneuver a fracture of the portion underneath the osteotomy line was caused, for this reason, it was necessary to perform a metallic cerclage at the fracture created.On (b)(6) 2011, the patient was discharged.

• Brand Name: UNKNOWN ORTHOPAEDICS SAW
• Type of Device: ORTHOPEDIC INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: morgan gray ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7590534
• MDR Text Key: 110709703
• Report Number: 0002249697-2018-01774
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 56 YR