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 Insufficient Information (4580)

Event Date 05/01/2017

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿centre ostéo-articulaire des cèdres, échirolles, france¿.The title of this report is ¿arthroscopic arthrodesis of the shoulder in brachial plexus palsy¿, published on may 01, 2017.Which is associated with the stryker ¿hoffman external fixation system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Jse.2016.09.040.This report includes an analysis of the clinical data that was collected on 8 patients.The cases in this study range from february 2012 to august 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.It was reported that 1 patient experienced poor tolerance of the external fixator under the skin, which required revision.The report states, ¿one acromiohumeral screw was removed together with the external fixator because it was poorly tolerated.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event regarding the poor tolerance of the external fixator under the skin, which required revision, 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.

Manufacturer Narrative

Please note correction to suspected medical device in section d.This includes the following; product long description, product code, and common device name.This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of poor tolerance of external fixator under the skin, which required revision could not be confirmed, 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.

Event Description

The manufacturer became aware of a literature published by the ¿centre ostéo-articulaire des cèdres, échirolles, france¿.The title of this report is ¿arthroscopic arthrodesis of the shoulder in brachial plexus palsy¿, published on may 01, 2017.Which is associated with the stryker ¿hoffman external fixation system¿.The article can be found at http://dx.Doi.Org/10.1016/j.Jse.2016.09.040.This report includes an analysis of the clinical data that was collected on 8 patients.The cases in this study range from february 2012 to august 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.It was reported that 1 patient experienced poor tolerance of the external fixator under the skin, which required revision.The report states, ¿one acromiohumeral screw was removed together with the external fixator because it was poorly tolerated.¿.

• 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: 14863634
• MDR Text Key: 295111926
• Report Number: 0008031020-2022-00305
• Device Sequence Number: 1
• Product Code: JDW
• 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: 08/18/2022

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: 06/08/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/18/2022
• 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