MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC DRIVER STAR 20 STRAIGHT ORTHOLOC 3DI PLATING SYSTEM; DRIVER, PROSTHESIS

Model Number	59250095
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Screwdriver blades from the ortholoc 3di ankle fusion system are broken at the tip when screwing in the locking screws.It was not known if debris was left in the patient.
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 reported event could be confirmed since the device was returned for evaluation and shows significant deformations at the tip of the instrument.The device inspection revealed the following: visual examination of the returned device shows scratches and blemishes indicative of reusable instruments.Significant deformations are visible at the tip of the instrument.The surface of the tip can be seen to be worn out and distorted.Fatigue cracks are visible on the tip surface.A hardness test conducted for the returned device produced the following results: hardness test 1: 54.1 hrc; hardness test 2: 56.1 hrc; hardness test 3: 54.4 hrc; average: 54.9 hrc.The results of the hardness test for the returned device are slightly lower than the expected value given in the material specification (hrc >=58).However, this can be attributed to the tolerance of the machine and measurement errors due to the small diameter and rounded surface of the device.Based on investigation, the root cause was attributed to a wear related issue.The failure was caused by normal wear and tear due to multiple use of the device over a prolonged period of time.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 more information is provided, the case will be reassessed.
Event or Problem Description
Screwdriver blades from the ortholoc 3di ankle fusion system are broken at the tip when screwing in the locking screws.It was not known if debris was left in the patient.

• Brand Name: DRIVER STAR 20 STRAIGHT ORTHOLOC 3DI PLATING SYSTEM
• Common Device Name: DRIVER, PROSTHESIS
• 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: 16247779
• Report Number: 3010667733-2023-00044
• Device Sequence Number: 6406231
• Product Code: HWR
• UDI-Device Identifier: 00889797022583
• UDI-Public: 00889797022583
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/27/2023

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: 59250095
• Device Catalogue Number: 59250095
• Device Lot Number: 1837623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown