MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX ELBOW LOCKING PLATE; IMPLANT

Catalog Number UNK_SEL

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

Patient Problem Tingling (2171)

Event Date 01/01/2012

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.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 university hospital (b)(6).The title of this report is ¿a post-market clinical follow-up of the treatment of elbow fractures with the variax elbow locking plate system¿ which is associated with the stryker ¿variax elbow locking plate¿ system.Within that publication, post-operative complications/ adverse events were reported, which occurred from 01/01/2012 to 31/12/2017.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 21 complaints were initiated retrospectively for adverse events mentioned in the report.This product inquiry addresses paresthesia.The report states: ¿woman, (b)(6) years old, bmi 24.80, stumbled while walking her dog and contracted a supra- and diacondylar humerus fracture on her left side.The patient is a non-smoker and has neither osteoporosis nor diabetes mellitus.No relevant secondary diseases are known.Operation of the fracture with stryker variax double osteosynthesis plate.After the operation, slight tingling paresthesia occurred in the area of the left arm, the diagnosis prolonged the stay.Healing without complications and discharge after 10 days.Complete regression after 6 months.¿.

• Brand Name: UNKNOWN VARIAX ELBOW LOCKING 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9538027
• MDR Text Key: 185766997
• Report Number: 0008031020-2020-00005
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 01/02/2020

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: 12/09/2019
• Initial Date FDA Received: 01/02/2020
• 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 Outcome(s): Other
• Patient Age: 80 YR