MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC HEADED SCREW 2.5MM X 12MM DART-FIRE COMPRESSION SCREW; SCREW, FIXATION, BONE

Catalog Number	D1N25012S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Ambulation or Postural Difficulties (2544); Cramp(s) /Muscle Spasm(s) (4521); Metal Related Pathology (4530)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.H3 other text : device not available.
Event or Problem Description
It was reported by the patient that the patient had a small screw system implanted in the left foot.Fourth left metatarsal bone in the toe, patient ended up with a rash, had implant removed 4 years post-op because she could barely walked.The patient was contacted by the fda requesting the lot number of the screw 9 years after the initial surgery.Patient believes she developed metal toxicity.
Additional Manufacturer Narrative
The reported event could be confirmed, since evaluation of medical records confirms the device was removed due to pain.A review of the provided documents and images was performed and reviewed by medical professionals.Based on the review no allegations against the device regarding allergic reaction or implant usage/design was made by the treating surgeons or medical imaging professionals.No further assessment was possible based on the imaging and/or documentation beyond what was already stated in the documents.The investigation determined these screws are manufactured from medical grade titanium alloy which is commonly used in the production of medical implants.This information is also found on the ifu provided with these implants.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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the patient that the patient had a small screw system implanted in the left foot.Fourth left metatarsal bone in the toe, patient ended up with a rash, had implant removed 4 years post-op because she could barely walked.The patient was contacted by the fda requesting the lot number of the screw 9 years after the initial surgery.Patient believes she developed metal toxicity.

• Brand Name: HEADED SCREW 2.5MM X 12MM DART-FIRE COMPRESSION SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17750106
• Report Number: 3010667733-2023-00534
• Device Sequence Number: 18022455
• Product Code: HWC
• UDI-Device Identifier: 00840420120434
• UDI-Public: 00840420120434
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: D1N25012S
• Device Lot Number: 1307598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 54 KG