MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX PINS; PIN, FIXATION, THREADED

Catalog Number UNK_SEL

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

Patient Problem Sepsis (2067)

Event Date 01/01/2017

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿professor of experimental rheumatology, rheumatology and clinical immunology, umc utrecht, netherlands ¿.The title of this report is ¿knee joint distraction compared with total knee arthroplasty: a randomised controlled trial ¿, published on january 1, 2017, which is associated with the stryker ¿monotube triax external fixation system¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/28053257.This report includes an analysis of the clinical data that was collected on 60 patients.The study was conducted between 2011 and 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available; however, it was reported that 1 patient experienced admission to the hospital shortly after removal of the frame for itnravenous antibiotics, due to staphyloccus aureus sepsis diagnosed from blood culture.There were possibly 8 pins involved.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿professor of experimental rheumatology, rheumatology and clinical immunology, umc utrecht, netherlands¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/28053257.  the reported event could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.  more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: UNKNOWN APEX PINS
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16048821
• MDR Text Key: 306155664
• Report Number: 0008031020-2022-00719
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2022
• 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): Required Intervention