MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC; BIT,DRILL

Catalog Number	03.010.228
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.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 during an original surgery on (b)(6) 2017 for an open reduction internal fixation (orif) of a femur, the surgeon planned to implant two (2) recons screws in total.As the surgeon inserted the first recon screw into the patient's femoral neck, the tip of the drill bit broke off.The length of the broken fragment was about 1 - 1.5 inches long.The surgeon decided not to retrieve the broken fragment as it could potentially cause more damage.The surgeon then processed to insert the second recon screw using another drill bit that was available.Both the recons screws were implanted in the patient and the surgery was completed successfully without any delay.The patient is reported to be in stable condition.Concomitant devices reported: recon screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) drill bit for 5.0mm recon screws/large qc.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part number: 03.010.228, synthes lot number: u151614: supplier lot number: (b)(4), release to warehouse date: 05 apr 2012, supplier: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC
• 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: 7126425
• Report Number: 2939274-2017-50353
• Device Sequence Number: 16483323
• Product Code: HTW
• UDI-Device Identifier: 10886982068101
• UDI-Public: (01)10886982068101(10)U151614
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/20/2017

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: 03.010.228
• Device Lot Number: U151614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/17/2018
• 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
• Patient Age: 17 YR
• Patient Weight: 74