MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; BIT,DRILL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information was not provided for reporting.This report is for one (1) unknown drill bit.Part#, lot# and udi # is not available.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown drill bit.Pma/510(k) number is not available.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 a screwdriver drill bit became stuck in the patient¿s bone during an open reduction internal fixation (orif) of periprosthetic femur (a percutaneous procedure) on (b)(6) 2017.The surgeon stated that this happens; there wasn't enough power to back the bit out.The surgeon had to back it out by hand and the screwdriver handle broke into a few pieces -which were all retrieved.Another device was available to back out the bit.All pieces were retrieved.No reported surgical delay.The procedure was completed successfully with the patient in stable condition.Concomitant device: unknown drill, part # unknown, lot # unknown, quantity unknown.This report is for one (1) unknown drill bit.(b)(4).

Manufacturer Narrative

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.

• Type of Device: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7173440
• MDR Text Key: 96862723
• Report Number: 2939274-2018-50116
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1