MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW,T8 FULL THREAD, 2.7MM/L14MM; SCREW, FIXATION, BONE

Catalog Number	656314S
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned since it is implanted in patient therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
Patient from belgium reported that he had surgery for a broken wrist.He had an allergic reaction to it.He would like to know which material cause allergy.
Additional Manufacturer Narrative
Correction: b2 - outcomes attributed to ae, d1 - product long description, g1 - manufacturing site for devices, h6 method code, h6 - health impact code grid.The reported event could not be confirmed since the device was not returned for evaluation and the provided image is also not conclusive to confirm the event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.As far as catering such requests are concerned, we need to be specific while replying to the question being asked as in this case as per instructions for use the plate is made up of titanium grade 2 material according to standard iso 5832 dash 2.As per the standard, it contains 0.03 percent carbon, 0.08 percent nitrogen, 0.0125 percent hydrogen, 0.3 percent iron, 0.25 percent oxygen and rest titanium.Apart from the plate, as per operative technique for variax 2 system the variax 2 screws are made of titanium alloy ti6ai4v according to astm f136 as per operative technique for variax 2 system.As per standard, it contains 0.05 percent max.Nitrogen, 0.08 percent max.Carbon, 0.012 percent max.Hydrogen, 0.25 percent max.Iron, 0.13 percent max.Oxygen, 5.5 to 6.5 percent aluminum, 3.5 to 4.5 percent vanadium and rest titanium.Although, the instructions for use with customers can be shared if it can address all the customer queries.Moreover, the customers or users can also access the instructions for use and operative technique using catalog or item number via labeling.Stryker.Com.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Patient from belgium reported that he had surgery for a broken wrist.He had an allergic reaction to it.He would like to know which material cause allergy.The allergy was discovered on (b)(6) 2023 the plate and screws were removed on (b)(6) 2023.

• Brand Name: LOCKING SCREW,T8 FULL THREAD, 2.7MM/L14MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19578409
• Report Number: 0008031020-2024-00248
• Device Sequence Number: 15576689
• Product Code: HWC
• UDI-Device Identifier: 07613327070682
• UDI-Public: 07613327070682
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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 Catalogue Number: 656314S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Required Intervention
• Patient Sex: Unknown