MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX 2 SLIM Y-PLATE (2 HOLES); IMPLANT

Catalog Number UNK_SEL

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.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 history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a pmcf from (b)(6), united states.The title of this report is ¿a retrospective data collection of the internal fixation of bones in the foot, ankle, hand, and wrist in adult and adolescent patients with the variax 2 foot system¿ which is associated with the stryker ¿variax 2 foot¿ system.Within that publication, post-operative complications/ adverse events were reported, for which data collection occurred from 7/30/2019 to 12/14/2019.It was not possible to ascertain specific device details from the report, 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 8 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses asymptomatic screw backout.The report states: ¿other one a screw pulled through a plate but had no adverse effects on the patient but was seen radiographically.The other patient who had a screw pull through their plate did not have any adverse effects and the patient went on to clinical consolidation.He was a lisfranc injury, therefore could not be evaluated for radiographic consolidation.¿.

• Brand Name: UNKNOWN VARIAX 2 SLIM Y-PLATE (2 HOLES)
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10009246
• MDR Text Key: 193612946
• Report Number: 0008031020-2020-01411
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• 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: 04/09/2020
• 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 Weight: 185