MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Myocardial Infarction (1969)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device evaluated by mfr: device disposition is unknown.

Event Description

This pi represents the myocardial infarction patient suffered between both surgeries.The pharmacist from the hospital reported the following event : "the consequences for the patient are therefore a double anaesthesia (2 operations instead of 1), and an extended operating time for the 1st operation.During the 2nd operation, the same problem.But the managers were very reactive to find an operational instrument.The 2nd operation (definitive nailing) took place 15 days later, with an extended hospital stay, increased discomfort for the patient due to the external fixator, in this elderly and fragile patient.In addition, between the two operations, she suffered a myocardial infarction, with a stay in cardiological intensive care, whose imputability for the surgery is difficult to prove.(this is my opinion as an orthopaedic surgeon, the opinion of an expert doctor could differ.

• Brand Name: UNKNOWN T2 NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8680334
• MDR Text Key: 147445843
• Report Number: 0009610622-2019-00481
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Weight: 60