MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN 1.2 MM VARIAX HAND PLATE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 04/01/2006

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.The ifu clearly states that ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.' ¿implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation.¿ a review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device disposition unknown.

Event Description

The manufacturer became aware of a literature report from (b)(6).The title of this report is ¿volar plating for unstable proximal interphalangeal joint dorsal fracture dislocations¿ which was published in january 2012 and is associated with stryker variax hand system.Within that publication, post-operative complications/ adverse events were reported, which occurred between april 2006 to april 2010.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication, therefore 14 complaint was initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses degenerative changes.3 out of 3 cases.The study states, ¿at 3 to 8 months, the pip joint in 3 patients showed degenerative changes that were defined as either decreased joint space compared with the initial postoperative radiograph or development of subchondral sclerosis seen on lateral radiograph.The changes were associated with mild pain and decreased motion in 2 patients and no pain or stiffness in 1.¿.

• Brand Name: UNKNOWN 1.2 MM VARIAX HAND PLATE
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8766946
• MDR Text Key: 150251631
• Report Number: 0008031020-2019-00774
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/08/2019
• 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