MAUDE Adverse Event Report: STRYKER GMBH T2 - LOCKING SCREW, FULLY THREADED D5X35 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965035S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by sales rep that the patient that was implanted in 2012 need to do a revision surgery due to the infection.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported by sales rep that the patient that was implanted in 2012 need to do a revision surgery due to the infection.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history record for the reported lot did not identify any abnormalities; therefore, no corrective actions are required at this time.The event description indicates that the initial surgery occurred in 2012; however, based on the provided catalog number and lot number, the device was manufactured in 2016, which does not match with provided details.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Surgical site infections (ssis) are a well-documented and relatively common complication following surgical procedures, with a global incidence of approximately 11% in general surgeries (gillespie, et al., 2021).In trauma surgeries, the risk is often elevated due to factors such as emergency conditions, open fractures, and limited time for optimal preoperative preparation.While it is theoretically possible for an infection to stem from a breach in the sterilization process at the manufacturing site, such occurrences are highly unlikely given the rigorous quality control systems, validated sterilization methods, and multiple checkpoints in place.More commonly, infections may arise from breaches in sterile techniques during handling, storage, or surgery itself - such as compromised packaging, improper transfer of the implant, or contamination during the procedure.Another main cause of post-operative wound infections (superficial and deep) may be related to post-operative factors, such as the open wound (even when closed with stitches/ staples), wound care/ hygiene, swelling/edema (inflammation), post-operative hematoma, etc.Additionally, patient-related factors, including their own microbiome, represent a significant and often unavoidable source of infection.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.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: T2 - LOCKING SCREW, FULLY THREADED D5X35 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA GMBH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24676564
• Report Number: 0008031020-2026-00459
• Device Sequence Number: 10285626
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 18965035S
• Device Lot Number: K092160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2016
• 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 Age: 64 YR
• Patient Sex: Unknown