MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN HOFFMANN II EXTERNAL FIXATOR; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number UNK_SEL

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

Patient Problem Malunion of Bone (4529)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿department of emergency, trauma center, changhai hospital, the second military medical university, china¿.The article can be found at https://doi.Org/10.1186/s12891-019-2679-9.The reported event of malunion, 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 ¿department of emergency, trauma center, changhai hospital, the second military medical university, china¿.The title of this report is ¿treatment of open tibial diaphyseal fractures by external fixation combined with limited internal fixation versus simple external fixation: a retrospective cohort study¿, published on july 03, 2019, and can be found at https://doi.Org/10.1186/s12891-019-2679-9.The report is associated with the stryker ¿hoffmann ii external fixation system¿ and includes an analysis of the clinical data that was collected on 152 patients.The cases in this study range from january 2012 and december 2016.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that 15 patients experienced malunion.

• Brand Name: UNKNOWN HOFFMANN II EXTERNAL FIXATOR
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 15272195
• MDR Text Key: 298381214
• Report Number: 0008031020-2022-00402
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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