MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX HAND LOCKING T-PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Date 03/01/2014

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the highlands-presbyterian/st.Luke¿s podiatric medicine and surgery residency program, colorado health foundation, us.The title of this report is, ¿a modified fixation technique for a decompressional shortening osteotomy: a retrospective analysis ¿, published on march 01, 2014, which is associated with the stryker ¿variax hand plating system¿.The article can be found at http://dx.Doi.Org/10.1053/j.Jfas.2013.12.018.This report includes an analysis of the clinical data that was collected on 30 patients.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 5 patients experienced hardware failure.2 patients experienced hardware failure.Initially surgeon used the 1.7-mm plate and then changed to the 2.3-mm plate because of hardware failure.2 patients experienced hypertrophic nonunion, along with plate breakage.1 patient experienced hypertrophic nonunion, and plate bending, along with floating toe.The report states, 2 patients had had hypertrophic nonunion (6%).No cases of malunion or avascular necrosis were recorded.In both cases of hypertrophic nonunion, we observed hardware failure due to plate breakage.The plate failed at the level of the empty screw hole over the osteotomy site.Overall, 5 cases (15.2%) of hardware failure resulted from breakage or bending of the plate.All the hardware failures occurred in patients who had been weightbearing in a walking boot postoperatively, and all the failures occurred in the titanium plates used at the beginning of the study, with the hole just proximal to the t left empty.We encountered 1 case of a floating toe (3%), in which the plate had bent at the apex of the osteotomy in a patient with nonunion.

Manufacturer Narrative

This record is a consolidation of events summarized as part of literature review, when device and patient information is not available.This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged hardware failure and hypertrophic nonunion 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.Device not available.

Manufacturer Narrative

Correction: please refer to h1 summary report & h1 number of events summarized.Please note the h1 summary report tab and h1 number of events summarized tab were selected in error.

Event Description

The manufacturer became aware of a literature published by the highlands-presbyterian/st.Luke¿s podiatric medicine and surgery residency program, colorado health foundation, us.The title of this report is, ¿a modified fixation technique for a decompressional shortening osteotomy: a retrospective analysis ¿, published on march 01, 2014, which is associated with the stryker ¿variax hand plating system¿.The article can be found at http://dx.Doi.Org/10.1053/j.Jfas.2013.12.018.This report includes an analysis of the clinical data that was collected on 30 patients.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 5 patients experienced hardware failure.- 2 patients experienced hardware failure.Initially surgeon used the 1.7-mm plate and then changed to the 2.3-mm plate because of hardware failure.- 2 patients experienced hypertrophic nonunion, along with plate breakage.- 1 patient experienced hypertrophic nonunion, and plate bending, along with floating toe.The report states, ¿[.] 2 patients had had hypertrophic nonunion (6%).No cases of malunion or avascular necrosis were recorded.In both cases of hypertrophic nonunion, we observed hardware failure due to plate breakage.The plate failed at the level of the empty screw hole over the osteotomy site.Overall, 5 cases (15.2%) of hardware failure resulted from breakage or bending of the plate.All the hardware failures occurred in patients who had been weightbearing in a walking boot postoperatively, and all the failures occurred in the titanium plates used at the beginning of the study, with the hole just proximal to the t left empty.We encountered 1 case of a floating toe (3%), in which the plate had bent at the apex of the osteotomy in a patient with nonunion.¿.

• Brand Name: UNKNOWN VARIAX HAND LOCKING T-PLATE
• Type of Device: PLATE, FIXATION, BONE
• 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: 14455827
• MDR Text Key: 294022164
• Report Number: 0008031020-2022-00235
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 06/02/2022
• 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