MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT QC 135MM 45MM CALIBRATION; BIT,DRILL

Model Number	03.133.102
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2020, the patient underwent an unknown procedure.During the procedure, the drill bit broke during drilling.The broken piece remained in the bone and another drill bit was used to complete the procedure.There was no surgical delay.The patient outcome is unknown.Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: 2.5MM DRILL BIT QC 135MM 45MM 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: 9996425
• Report Number: 2939274-2020-02033
• Device Sequence Number: 4483247
• Product Code: HTW
• UDI-Device Identifier: 10886982269614
• UDI-Public: (01)10886982269614
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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: 03.133.102
• Device Catalogue Number: 03.133.102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5MM DRILL BIT QC 135MM 45MM CALIBRATION; UNK - DRILL
• Outcome Attributed to Adverse Event: Required Intervention