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

Model Number	03.010.228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Additional medical/surgical intervention required/surgical intervention required.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: the investigation could not be completed; no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventive 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 (b)(6) 2019, when drilling the recon screws in synthes adolescent lateral entry femoral nail, the drill bit for recon broke and the broken piece had to be left inside of the patient.If remove, the broken pieces would've created more damage trying to get it out.The surgeon used different locking holes in the nail to complete the procedure, it was successfully completed with the delay of 15 minutes.Patient status were unknown.Concomitant device reported: unk - screws: trauma (part # unknown, lot # unknown, quantity # 1), unk - nails: femoral (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• 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: 8667223
• Report Number: 2939274-2019-58434
• Device Sequence Number: 2207345
• Product Code: HTW
• UDI-Device Identifier: 10886982068101
• UDI-Public: (01)10886982068101
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 03.010.228
• Device Catalogue Number: 03.010.228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 68