MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DIRECT MEASURING DEVICE FOR 3.2MM GUIDE WIRES; GAUGE,DEPTH

Model Number	03.168.003
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Only event year is known.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 or Problem Description
It was reported that on an unknown date, during femoral neck system (fns) procedure the surgeon penetrated the femoral head with the triple reamer.The surgeon measured it with 87mm and set the reamer to 80mm and the reamer still penetrated to the head.The triple reamer was advanced farther into femoral head than intended and possibility exists.The reamer was possibly set to a length that was too long but that was not confirmed and did not occur at the time of the procedure.According to the surgeon, patient is pain free and wants to weight bear.The surgeon is treating the patient conservatively for now but plans to allow weight bearing soon.There was no surgical delay.Patient and procedure outcome were unknown.Concomitant device reported: bolt for femoral neck system 90mm length-sterile (part number 04.168.290s, lot unknown, quantity 1), complete opening drill bit/ reamer assembly (part number 03.168.004, lot unknown, quantity 1).This report involves one (1) direct measuring device for 3.2mm guide wires.This is report 2 of 2 for (b)(4).

• Brand Name: DIRECT MEASURING DEVICE FOR 3.2MM GUIDE WIRES
• Common Device Name: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10074299
• Report Number: 2939274-2020-02453
• Device Sequence Number: 3358500
• Product Code: HTJ
• UDI-Device Identifier: 10886982274502
• UDI-Public: (01)10886982274502
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.168.003
• Device Catalogue Number: 03.168.003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE; COMPLETE OPENING DRILL BIT/ REAMER ASSEMBLY
• Outcome Attributed to Adverse Event: Required Intervention