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 Problems Unspecified Infection (1930); Osteomyelitis (4533)

Event Date 09/26/2019

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of pin site infection and osteomyelitis 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 ¿orthopaedic department, scarborough hospital, united kingdom¿.The title of this report is, ¿temporizing external fixation for hind foot trauma¿, published on september 26, 2019, which is associated with the stryker ¿hoffmann ii external fixation system¿.This report includes an analysis of the clinical data that was collected on 14 patients, and the cases in this study range from 2010 to 2017.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 pin site infection and osteomyelitis.

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 pin site infection and osteomyelitis 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 ¿orthopaedic department, scarborough hospital, united kingdom¿.The title of this report is, ¿temporizing external fixation for hind foot trauma¿, published on september 26, 2019, which is associated with the stryker ¿hoffmann ii external fixation system¿.This report includes an analysis of the clinical data that was collected on 14 patients, and the cases in this study range from 2010 to 2017.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 pin site infection and osteomyelitis.

• 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: 15059970
• MDR Text Key: 296212714
• Report Number: 0008031020-2022-00342
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• 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: 07/28/2022
• 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): Other