MAUDE Adverse Event Report: STRYKER GMBH PLATE TRIAL VARIAX FOR HOOK PLATE DEPTH - 12MM LEFT; PLATE, FIXATION, BONE

Model Number 703870

Device Problem Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2022

Event Type  Injury  

Event Description

It was reported that a surgeon used a trial plate for variax clavicle (hook plate) on the patient.The surgeon would like to know what problems the patient could have with this plate and will extract the trial plate.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.This investigation was worked on very closely with the r&d department, and the answers to the customer's questions are the following, according to an r&d expert: " i quickly checked the dhf and testing we have on the trials: implant trial material: 07.04.003 / ti6al4v eli 07.04.003 / ti6al4v eli surface treatment type ii type iii.Overall the trial has passed cleaning and sterilization [.] and biocompatibility testing [.].From an outer geometry and pate thickness the implant and trial is identical and subsequently the mechanical strength is of no big concern [.] " therefore, from a material perspective, both the trial and the implant are made from the same material.The trial has passed the cleaning and sterilization, as well as the biocompatibility testing.Furthermore, from an outer geometry and pate thickness the implant and trial is identical and subsequently the mechanical strength is of no big concern.However, one major difference that is important to bring up is the fact that the trial plate does not have screw holes that are the same size as the implant.The customer was asked about which screw were used, and the response was mostly variax screws.This could be an issue since the trial plate holes have a diameter of 6mm while the implants have a smart look hole diameter of max.4mm and the variax 2 biggest screw head to be used is the t10, 3.5mm non-locking screw with a max.5mm screw head.The fixation is only feasible within the oblong hole.Using variax screws in the other holes could lead to complications such as migration of screws, and movement of the plate.The root cause of the event was classified as user related, since the hcp implanted the trial by error, which is clearly cautioned against in the ifu.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 more information is provided, the case will be reassessed.

• Brand Name: PLATE TRIAL VARIAX FOR HOOK PLATE DEPTH - 12MM LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15526244
• MDR Text Key: 301014468
• Report Number: 0008031020-2022-00497
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327089295
• UDI-Public: 07613327089295
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/02/2022

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: Health Professional
• Device Model Number: 703870
• Device Catalogue Number: 703870
• Device Lot Number: D28675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention