MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC TI NON LOCK SCREW 3.5 X 40MM DARCO SYSTEM; SCREW, FIXATION, BONE

Model Number	777350802
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw head broke off during insertion.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual inspection: visual examination of the received product shows that screw received has an intact tip and shaft thread, but the screw head is in a badly damaged and deformed condition.The hex is completely worn from too much force and the ring from the top head end of the screw is deformed, furthermore the wall between the head diameter and the worn hex got burst.The damage at the screw head is most likely the result from removal with pliers.Dimensional inspection: outer diameter of the shaft thread, diameter 3.50mm +0/-0.15 = result 3.42mm and outer screw head diameter, diameter 3.50mm +0/-0.15 = result 3.46mm.Tested with calipper no.4525 , the measure results are within accuracy.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 catalog number and lot number were not communicated.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely by to much force.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the screw head broke off during insertion.

• Brand Name: TI NON LOCK SCREW 3.5 X 40MM DARCO SYSTEM
• 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: 16353084
• Report Number: 3010667733-2023-00061
• Device Sequence Number: 6824585
• Product Code: HWC
• UDI-Device Identifier: 00840420106650
• UDI-Public: 00840420106650
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K061808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 777350802
• Device Catalogue Number: DC2820140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown