MAUDE Adverse Event Report: STRYKER GMBH 1.7 S VARIAX HAND LOCK T-PLATE,NAR,6L; PLATE, FIXATION, BONE

Model Number	57-10340
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on information provided, the root cause was attributed to an user related issue.A non-sterile implant was implanted, which should be strictly avoided due to risks of infection.As a reminder, the instructions for use clearly state: "products not labelled as sterile are non-sterile.In the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "a patient has had a non sterile finger plate from the variax 2 hand plating system implanted.This was identified by the hospital nurse when she looked at the device packaging following the operation." it was an open reduction and internal fixation of a finger fracture.

• Brand Name: 1.7 S VARIAX HAND LOCK T-PLATE,NAR,6L
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15825658
• Report Number: 0008031020-2022-00622
• Device Sequence Number: 6143430
• Product Code: HRS
• UDI-Device Identifier: 07613154496334
• UDI-Public: 07613154496334
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 57-10340
• Device Catalogue Number: 57-10340
• Device Lot Number: 1000466416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown