MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN MONOTUBE TRIAX EXTERNAL FIXATOR; IMPLANT

Catalog Number UNK_SEL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Deformity/ Disfigurement (2360); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/01/2019

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 pediatric orthopedics and traumatology, istituto ortopedico rizzoli, via pupilli, bologna, italy.¿ the article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/30789537.  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.Device disposition: unknown.

Event Description

The manufacturer became aware of a literature published by the ¿department of pediatric orthopedics and traumatology, istituto ortopedico rizzoli, via pupilli, bologna, italy.¿ the title of this report is ¿complications during the treatment of missed monteggia fractures with unilateral external fixation: a report on 20 patients in a 10-year period in a tertiary referral center,¿ published on may 1, 2019, which is associated with the stryker ¿monotube triax external fixation system.¿ the article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/30789537.This report includes an analysis of the clinical data that was collected on 20 patients.The study was conducted between 2006 and 2016.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; however, it was reported that 1 patient experienced deformity of the forearm.

Manufacturer Narrative

Please disregard mdr mfr# 0008031020-2022-00702.Upon further medical healthcare professional re-assessment of the available information, it was concluded that the surgeon was not able to correct the preoperative deformity completely.After lengthening the ulna, a residual deformity stayed present (referred to as the final deformity) with some residual dislocation of the radial head.Where the patient gained on flexion/extension, she lost some on pro- and supination.Therefore it was concluded that the ¿fair¿ outcome of case 8 is fracture type related, thus patient related, and not device related.

Event Description

The manufacturer became aware of a literature published by the ¿department of pediatric orthopedics and traumatology, istituto ortopedico rizzoli, via pupilli, bologna, italy ¿.The title of this report is ¿complications during the treatment of missed monteggia fractures with unilateral external fixation: a report on 20 patients in a 10-year period in a tertiary referral center ¿, published on may 1, 2019, which is associated with the stryker ¿monotube triax external fixation system¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/30789537.This report includes an analysis of the clinical data that was collected on 20 patients.The study was conducted between 2006 and 2016.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; however, it was reported that 1 patient experienced deformity of the forearm.Further medical review of the available information reveled the following: in case 8 the surgeon was not able to correct the preoperative deformity completely.After lengthening the ulna, a residual deformity stayed present (referred to as the final deformity) with some residual dislocation of the radial head.Where the patient gained on flexion/extension, she lost some on pro- and supination.It illustrated the 3d-complexity of the monteggia type ulnar fracture, that in not in all cases can be corrected with this surgical method of ulnar distraction.Therefore it was conclude that the ¿fair¿ outcome of case 8 is fracture type related, thus patient related, and not device related.

Manufacturer Narrative

Please note corrections to h6 (conclusion code) this complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of deformity of the forearm 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 ¿department of pediatric orthopedics and traumatology, istituto ortopedico rizzoli, via pupilli, bologna, italy ¿.The title of this report is ¿complications during the treatment of missed monteggia fractures with unilateral external fixation: a report on 20 patients in a 10-year period in a tertiary referral center ¿, published on may 1, 2019, which is associated with the stryker ¿monotube triax external fixation system¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/30789537.This report includes an analysis of the clinical data that was collected on 20 patients.The study was conducted between 2006 and 2016.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; however, it was reported that 1 patient experienced deformity of the forearm.

Manufacturer Narrative

Please disregard mdr mfr# 0008031020-2022-00702 as this event was initially reported as device related event however upon further healthcare professional review of the available information it was concluded as patient related.

Event Description

The manufacturer became aware of a literature published by the ¿department of pediatric orthopedics and traumatology, istituto ortopedico rizzoli, via pupilli, bologna, italy ¿.The title of this report is ¿complications during the treatment of missed monteggia fractures with unilateral external fixation: a report on 20 patients in a 10-year period in a tertiary referral center ¿, published on may 1, 2019, which is associated with the stryker ¿monotube triax external fixation system¿.The article can be found at https://www.Ncbi.Nlm.Nih.Gov/pubmed/30789537.This report includes an analysis of the clinical data that was collected on 20 patients.The study was conducted between 2006 and 2016.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; however, it was reported that 1 patient experienced deformity of the forearm.Further medical review of the available information reveled the following: in case 8 the surgeon was not able to correct the preoperative deformity completely.After lengthening the ulna, a residual deformity stayed present (referred to as the final deformity) with some residual dislocation of the radial head.Where the patient gained on flexion/extension, she lost some on pro- and supination.It illustrated the 3d-complexity of the monteggia type ulnar fracture, that in not in all cases can be corrected with this surgical method of ulnar distraction.Therefore it was conclude that the ¿fair¿ outcome of case 8 is fracture type related, thus patient related, and not device related.

• Brand Name: UNKNOWN MONOTUBE TRIAX EXTERNAL FIXATOR
• Type of Device: IMPLANT
• 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: 16021733
• MDR Text Key: 305875825
• Report Number: 0008031020-2022-00702
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• 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: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Sex: Female