MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC HEADED SCREW 2.0MM X 14MM DART-FIRE COMPRESSION SCREW; SCREW, FIXATION, BONE

Catalog Number	D1N20014S
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Implant Pain (4561)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient is having a reaction to the screws that were implanted.The screws "bother her" and still hurt.The patient is having sensitivity to touch where the implants are located.The patient mentioned that the screws are also loosening and may need to have revision surgery to remove the screws.
Additional Manufacturer Narrative
The complaint could be confirmed, since the returned information for evaluation matches the alleged failure, although the product wasn¿t returned for evaluation.An inspection of the images together with medical professional has shown the following: 2 screws are visible on the received images.The second screw doesn¿t seem to be a problem.Further evaluation of the received information revealed the following: dar-fire 2.0 screws are made from raw material ti6al4v (ti titanium, al aluminum, v vanadium, fe iron, o oxygen, n nitrogen, c carbon, h hydrogen).Based on that, ti6al4v is not made with ni nickel, co cobalt and cr chromium, which are known for body intolerances.In this regards ti6al4v is referred as non-allergic material.For further and detailed information to the material of the screws implanted we would need the article and lot combination of the products.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.More detailed information about the complaint event 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.

• Brand Name: HEADED SCREW 2.0MM X 14MM 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: 19520961
• Report Number: 3010667733-2024-00367
• Device Sequence Number: 15588534
• Product Code: HWC
• UDI-Device Identifier: 00840420120328
• UDI-Public: 00840420120328
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: D1N20014S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/12/2024
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG