MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 5 HOLE / 12MM / LEFT; PLATE, FIXATION, BONE

Model Number	628505S
Medical Device Problem Codes	Off-Label Use (1494); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device remains implanted in patient.
Event or Problem Description
As reported: "variax clavicle hook plate was used with a another company's anchor for reduction of patient's left clavicle on (b)(6) 2023.On (b)(6) 2023, it was found that the hook plate was dislodged (placed over the acromion).Since the anchor works properly, there is no significant reduction loss at this time.".
Event or Problem Description
As reported: "variax clavicle hook plate was used with a another company's anchor for reduction of patient's left clavicle on (b)(6) 2023.On (b)(6) 2023, it was found that the hook plate was dislodged (placed over the acromion).Since the anchor works properly, there is no significant reduction loss at this time.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.It was indicated in the event description that an anchor from another manufacturer was used for fracture reduction.This should be strictly avoided, as indicated by the instructions.As a reminder, the instructions for use clearly state that: "do not use components of stryker product systems in conjunction with components from any other manufacturer¿s system unless otherwise specified (see operative technique)".However, due to the lack of evidence, it was not possible to state to which extend this could have influenced the implant dislocation.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.

• Brand Name: HOOK PLATE VARIAX CLAVICLE 5 HOLE / 12MM / LEFT
• Common Device Name: 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: 16957456
• Report Number: 0008031020-2023-00206
• Device Sequence Number: 20561836
• Product Code: HRS
• UDI-Device Identifier: 07613327085389
• UDI-Public: 07613327085389
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: Lay User/Patient
• Device Model Number: 628505S
• Device Catalogue Number: 628505S
• Device Lot Number: H59390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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