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 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 malunion, 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.

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 malunion, requiring revision.The report states, ¿further complex surgery was required for malnunion¿.

Manufacturer Narrative

Based on the information received from the author, there were no issues with the fixator.Instead, the article is about clinical judgement not the tools.Thus, based on additional information, this case is subsequently considered as non-reportable.

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 malunion, requiring revision.The report states, ¿further complex surgery was required for malnunion¿.06/22/2022: new information received from the author states that there were no issues with the fixator.Instead, the article is about clinical judgement, not the tools.

• 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: 15059847
• MDR Text Key: 296212060
• Report Number: 0008031020-2022-00343
• Device Sequence Number: 1
• Product Code: KTT
• 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: 08/19/2022

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: 07/20/2022
• 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