MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L55MM; SCREW, FIXATION, BONE

Catalog Number	657455
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Implant Pain (4561)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "patient following with podiatry for retained and painful hardware.Failed conservative measures.During surgery for removal, screw noted to be broken proximally.Decision made to remove only the proximal portion of the screw and leave the distal aspect intact.".
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 on a supplemental report.

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L55MM
• 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: 20872383
• Report Number: 0008031020-2024-00638
• Device Sequence Number: 15663195
• Product Code: HWC
• UDI-Device Identifier: 07613327074291
• UDI-Public: 07613327074291
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 657455
• 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: 11/12/2024
• Initial Report FDA Received Date: 12/06/2024
• 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: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White