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

Catalog Number	57-10316
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8210622
• Report Number: 0008031020-2019-00004
• Device Sequence Number: 2179394
• Product Code: HRS
• UDI-Device Identifier: 07613154496303
• UDI-Public: 07613154496303
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 57-10316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2018
• Initial Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR