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

Model Number	59250095
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the tip of the driver broke off during use inserting a screw.The tip could not be removed from screw so the surgeon removed and replaced the screw.
Event or Problem Description
It was reported that the tip of the driver broke off during use inserting a screw.The tip could not be removed from screw so the surgeon removed and replaced the screw.
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 the star recess tip is broken off as reported, the broken off part did not get returned for evaluation.The screw driver is in a well-used condition, with marks of scratches and discoloration around the screw driver, especially on the shaft there is a scratch mark which is most likely from contact to another part.The tip section is showing that the star recess tip got twisted by tightening, before it sheared off, also there a stress marks from high applied mechanical force visible, visible as hairline cracks.All dimensional and material integrity inspections which have been taken are within accuracy.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.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely by to much force.If more information is provided, the case will be reassessed.

• Brand Name: 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: 15694410
• Report Number: 3010667733-2022-00367
• Device Sequence Number: 7359582
• Product Code: HWR
• UDI-Device Identifier: 00889797022583
• UDI-Public: 00889797022583
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: 2232559
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2020
• 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