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

Catalog Number UNK_SEL

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition unknown.

Event Description

The manufacturer became aware of a study from department of orthopedic surgery, bürgerspital solothurn.The title of this study is ¿the first 100 patients treated with a new anatomical pre-contoured locking plate for clavicular midshaft fractures¿ and is associated with the variax clavicle locking plate system.Within that publication, post-operative complications/ adverse events were reported, which occurred between march 2012 and january 2016.It was not possible to ascertain specific device catalogs 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 46 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses failed osteosynthesis because of surgical implantation fault.1 out of 2 cases.The study states, ¿failures occurred due to surgical errors where the medial screws were not placed bi-cortically, with subsequent medial plate loosening¿.

• Brand Name: UNKNOWN VARIAX 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8368328
• MDR Text Key: 137117612
• Report Number: 0008031020-2019-00126
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/25/2019

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: 02/03/2019
• Initial Date FDA Received: 02/25/2019
• 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): Required Intervention