MAUDE Adverse Event Report: STRYKER GMBH HOOK PLATE VARIAX CLAVICLE 7 HOLE / 12MM / LEFT; PLATE, FIXATION, BONE

Catalog Number	628507S
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that an expired implant was implanted in the patient.Update nov 14/11 - patient was revised.
Event or Problem Description
It was reported that an expired implant was implanted in the patient.Update nov 14/11 - patient was revised.
Additional Manufacturer Narrative
Please note corrections to h6 device code.The reported event could be confirmed based on the information provided and based on the inspection performed on the documentation of the lot number communicated.The inspection of manufacturing documents confirmed that the sterility of the device had already expired when the implantation was performed.Based on investigation, the root cause was attributed to a user related issue.Hcp failed to properly inspect the device's sterility expiry date prior to the implantation.As a reminder, the instructions for use clearly state: the packaging of all sterile products should be inspected before opening.In the presence of flaws, if the packaging was unintentionally opened before use or expiration of shelf life, the product must be assumed 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.As stated by medical experts: in case of the expiration of shelf-life stryker cannot guarantee the performance and safety for use.Re-sterilization is only possible for those devices where stryker explicitly describes a re-sterilization process it in the ifu.The risk of infection will increase with the time passed after the expiry date which is printed on the packaging.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 7 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: 20898345
• Report Number: 0008031020-2024-00642
• Device Sequence Number: 14715508
• Product Code: HRS
• UDI-Device Identifier: 07613327085624
• UDI-Public: (01)07613327085624(17)240731(10)D34683
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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 Expiration Date: 07/31/2024
• Device Catalogue Number: 628507S
• Device Lot Number: D34683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown