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

Model Number 5202000016

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

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 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
• Type of Device: 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
• MDR Text Key: 300912779
• Report Number: 3010667733-2022-00300
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 00889797059916
• UDI-Public: 00889797059916
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1