MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION; BIT,DRILL

Catalog Number	03.010.062
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.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.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a surgeon had a case involving a femoral shaft fracture on (b)(6) 2018 in which the retrograde and anterograde femoral system was used.Upon arriving into the room, the sales consultant asked the surgical tech to gather all of the instrumentation out of our tray and place the instrumentation on the back table.Sales consultant told the surgical tech to get the 4.2mm drill bit, but unfortunately the surgical tech reached out and took the 5.0mm drill bit.The 5.0mm drill bit was taken out and loaded into the drill.Once loaded into the drill, the specific size of the drill couldn¿t be determined because the drill covered it up.This mistake was not realized until a measurement was taken for the screw length.Upon realizing the mistake, the surgeon decided to drill an additional screw hole through the anterior/posterior hole.A total of 3 out of 4 distal screw holes were utilized in the implant.Implanted screws were not malfunctioned or compromised.The surgery was completed successfully and the patient outcome was satisfactory.Concomitant part: screws (unknown part and lot number, quantity three).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Date reported in (b)(4) was (b)(6) 2018.Correct date should have been (b)(6) 2018.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: 5.0MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7384944
• Report Number: 2939274-2018-51350
• Device Sequence Number: 19180736
• Product Code: HTW
• UDI-Device Identifier: 10886982067357
• UDI-Public: (01)10886982067357(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2018

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 Catalogue Number: 03.010.062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 01/07/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention