MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN ASNIS 6.5/8.0MM TITANIUM CANNULATED SCREW; SCREW, FIXATION, BONE

Catalog Number UNK_SEL

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

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Date 09/02/2019

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿interventional radiology unit, imaging department, gustave roussy cancer campus, france ¿.The title of this report is ¿ct guidance assisted by electromagnetic navigation system for percutaneous fixation by internal cemented screws (fics) ¿, published on september 02, 2019.Which is associated with the stryker ¿asnis iii cannulated screw system¿.The article can be found at https://doi.Org/10.1007/s00330-019-06408-0.This report includes an analysis of the clinical data that was collected on 50 patients.The cases in this study range from december 2017 to august 2018.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.It was reported that 1 patient experienced infection of the hematoma, which required screw removal.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿interventional radiology unit, imaging department, gustave roussy cancer campus, france ¿.The article can be found at https://doi.Org/10.1007/s00330-019-06408-0.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.

Event Description

The manufacturer became aware of a literature published by the ¿interventional radiology unit, imaging department, gustave roussy cancer campus, france ¿.The title of this report is ¿ct guidance assisted by electromagnetic navigation system for percutaneous fixation by internal cemented screws (fics) ¿, published on september 02, 2019.Which is associated with the stryker ¿asnis iii cannulated screw system¿.The article can be found at https://doi.Org/10.1007/s00330-019-06408-0.This report includes an analysis of the clinical data that was collected on 50 patients.The cases in this study range from december 2017 to august 2018.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.It was reported that 1 patient experienced infection of the hematoma, which required screw removal.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of infection of the hematoma, which required screw removal, since no additional information was received from the author or the article.More detailed information about the patient medical history, the event circumstances, and medical reports 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 ASNIS 6.5/8.0MM TITANIUM CANNULATED SCREW
• Type of Device: SCREW, FIXATION, BONE
• 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: 15639424
• MDR Text Key: 302083770
• Report Number: 0008031020-2022-00553
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: 11/02/2022
• 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