MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC DRIVER STAR 7 ORTHOLOC PLATING SYSTEM; DRIVER, PROSTHESIS

Model Number	5202000016
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the screwdriver shaft broke off and remained in the screw head.The hook portion of the depth gauge was severely bent.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the front end or tip of the received driver is broken and the microscopic image of the fracture site indicates it primarily to be torsional overload fracture along with secondary fatigue indicated by lines of rest.The hook of the depth gage is also bent due to excessive bending force.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿use medical devices in accordance with their labeled indications and the manufacturer¿s instructions for use, especially during insertion and removal.Inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure.Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.If the device is damaged, retain it to assist with the manufacturer¿s analysis of the event.¿ based on investigation, the root cause was attributed to a user related issue i.E.Torsional overload fracture.The failure was caused by due to torsion of the device which broke on the application of high forces.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the tip of the screwdriver shaft broke off and remained in the screw head.The hook portion of the depth gauge was severely bent.

• Brand Name: DRIVER STAR 7 ORTHOLOC 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: 15371919
• Report Number: 3010667733-2022-00300
• Device Sequence Number: 6250898
• Product Code: HWR
• UDI-Device Identifier: 00889797059916
• UDI-Public: 00889797059916
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/06/2023

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: 5202000016
• Device Catalogue Number: 5202000016
• Device Lot Number: 2180707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown