MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, T10, 3.5X16MM; PLATE, FIXATION, BONE

Catalog Number	40-35616
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Eczema (4547)
Date of Event	03/19/2024
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.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
It was reported that patient underwent ankle surgery on (b)(6) 2024, using a 9-hole 1/3 tubular plate with a combination of locking and non-locking screws, as well as two 4.0 mm partially threaded cannulated screws with washers.The patient developed eczema shortly after surgery, possibly due to an allergic reaction to the implant.A patch test with a local allergist is pending to determine if the plate and screws are the cause.The metallic composition of the implants is unclear, and more information is needed to determine if they are made of titanium or alloys.The patient's representative emphasized that they are not filing a complaint or requesting an investigation but are seeking details on the metals used in the implant to rule out a metal allergy.

• Brand Name: LOCKING SCREW, T10, 3.5X16MM
• 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: 20222498
• Report Number: 0008031020-2024-00482
• Device Sequence Number: 15385275
• Product Code: HRS
• UDI-Device Identifier: 07613154628698
• UDI-Public: 07613154628698
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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: 40-35616
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 09/16/2024
• 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
• Patient Sex: Female
• Patient Weight: 50 KG