MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6MM DRILL TIP GUIDE WIRE 200MM; PIN,FIXATION,SMOOTH

Model Number 02.113.001

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.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.

Event Description

It was reported that on (b)(6) 2020, during an unknown procedure a 30mm portion of the 1.6 drill tip guide wire was retained in the patient's right midshaft tibia.There was no surgical delay reported.There was no adverse effect during the surgery.Patient status was stable.This report involves one (1) 1.6mm drill tip guide wire 200mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.6MM DRILL TIP GUIDE WIRE 200MM
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10075409
• MDR Text Key: 192050787
• Report Number: 2939274-2020-02460
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886982034717
• UDI-Public: (01)10886982034717
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080943
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.113.001
• Device Catalogue Number: 02.113.001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR