MAUDE Adverse Event Report: STRYKER GMBH 1.7 S VARIAX HAND LOCK PLATE,STRAI,16HOLES; PLATE, FIXATION, BONE

Catalog Number 57-10316

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Failed variax hand plates.Noticed after follow up x-ray.Revision surgery required.

• Brand Name: 1.7 S VARIAX HAND LOCK PLATE,STRAI,16HOLES
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8210622
• MDR Text Key: 131890320
• Report Number: 0008031020-2019-00004
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154496303
• UDI-Public: 07613154496303
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K062498
• 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: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 57-10316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2018
• 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
• Patient Age: 58 YR