MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC

Model Number 03.620.022

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Perforation of Vessels (2135)

Event Date 01/08/2019

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2019, the patient underwent a lumbar spondylosis stenosis, radiculopathy, xl1f l3-4, open posterior revision with l3-5 decompression posterior lateral fusion instrumentation, l3-s1, screws, rods, allograft.This revision was related to the previous surgery in which, a screwdriver was broken and lacerated patient's iliac artery.This event is captured in related complaint (b)(4).This report is for a screwdriver.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T25/SHORT/6MM HXC
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14598196
• MDR Text Key: 293341687
• Report Number: 2939274-2022-02084
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034717616
• UDI-Public: (01)10705034717616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.620.022
• Device Catalogue Number: 03.620.022
• Device Lot Number: 5143771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 92 KG