MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN K-WIRE; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES

Catalog Number UNK_SEL

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

Patient Problem Implant Pain (4561)

Event Date 03/01/2019

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿university of medicine and pharmacy carol davila bucharest, st.Pentelimon emergency hospital, romania.¿the title of this report is ¿association of kirschner wires and shape-memory staple in four-corner arthrodesis ¿, published on march 01, 2019, which is associated with the stryker ¿easyclip¿ system.This report includes analysis of the clinical data that was collected on 12 patients, and the cases in this study range from 2012 and 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 3 patients experienced pain.The report also states, ¿in 2 cases (16.67%) we found pain with forceful demands, and in one case (8.33%) pain was present in day-life activity.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pain 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 medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

Event Description

The manufacturer became aware of a literature published by the ¿university of medicine and pharmacy carol davila bucharest, st.Pentelimon emergency hospital, romania.¿the title of this report is ¿association of kirschner wires and shape-memory staple in four-corner arthrodesis ¿, published on march 01, 2019, which is associated with the stryker ¿easyclip¿ system.This report includes analysis of the clinical data that was collected on 12 patients, and the cases in this study range from 2012 and 2014.During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available.It was reported that 3 patients experienced pain.The report also states, ¿in 2 cases (16.67%) we found pain with forceful demands, and in one case (8.33%) pain was present in day-life activity.¿.

Manufacturer Narrative

Correction: link to the published article: https://doi.Org/10.31688/abmu.2019.54.1.15.

• Brand Name: UNKNOWN K-WIRE
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES
• 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: 14204758
• MDR Text Key: 290049385
• Report Number: 0008031020-2022-00198
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: RO
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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?: 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
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/08/2024
• 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): Other