MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X38MM TL13MM; SCREW, FIXATION, BONE

Model Number	604638S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
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
It was reported that an expired device was implanted into the patient.
Additional Manufacturer Narrative
The reported event could be confirmed since as per the device information, it expired on 31st october 2022 while the surgery happened on (b)(6) 2022.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Information regarding the device, including its expiration date is clearly available on its packaging.Therefore, it is the responsibility of the operating surgeon and the staff to check that before the surgery.Even, if the shelf life is exceeded, it is recommended to re-sterilize the device before use.This is required as per ifu.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.Within the labelling there are statements referring to the expiration of shelf life, : ¿in the event of contamination, 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.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that an expired device was implanted into the patient.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X38MM TL13MM
• Common Device Name: SCREW, 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: 16048863
• Report Number: 0008031020-2022-00722
• Device Sequence Number: 6258367
• Product Code: HWC
• UDI-Device Identifier: 04546540089748
• UDI-Public: 04546540089748
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K213199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 604638S
• Device Catalogue Number: 604638S
• Device Lot Number: L40751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 12/26/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• 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