MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC EVOLVE TRIAD SCREW 2.0X18MM NON LOCKING BONE; SCREW, FIXATION, BONE

Catalog Number	4942018N
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	03/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while inserting 2.0x18mm screw into bone after pre-drilling with appropriate drill bit the screw head broke off of the body of the screw leaving the screw body and threads behind.After using a trephine reamer to attempt to remove screw from bone, the screw broke again.This resulted in a larger hole left behind in patient and caused us to remove plate and reposition plate.This resulted in a 30 minutes delay.Additional anesthesia, additional tourniquet time.
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.H3 other text : device not available.
Additional Manufacturer Narrative
Correction h6 results code.The complaint could be confirmed, since the information for evaluation matches the alleged failure.The investigation revealed the following: an inspection of the received x-ray's has shown that indeed on one (1) a screw with no head is visible, on an another one (1) it is clearly visible that the broken screw could be removed, as only the hole is visible anymore.Furthermore, on all x-ray's are following non-damaged parts are visible, three (3) wires and two (2) screws, the mentioned plate couldn't be located.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.
Event or Problem Description
It was reported while inserting 2.0x18mm screw into bone after pre-drilling with appropriate drill bit the screw head broke off of the body of the screw leaving the screw body and threads behind.After using a trephine reamer to attempt to remove screw from bone, the screw broke again.This resulted in a larger hole left behind in patient and caused us to remove plate and reposition plate.This resulted in a 30 minutes delay.Additional anesthesia, additional tourniquet time.

• Brand Name: EVOLVE TRIAD SCREW 2.0X18MM NON LOCKING BONE
• 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: 19055196
• Report Number: 3010667733-2024-00186
• Device Sequence Number: 17986389
• Product Code: HWC
• UDI-Device Identifier: 00840420116048
• UDI-Public: 00840420116048
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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: Health Professional
• Device Catalogue Number: 4942018N
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 34 YR
• Patient Sex: Unknown