MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM; BIT, DRILL

Model Number	03.130.100
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record.Device history lot: part number: 03.130.100, synthes lot number: u354366.Manufactured by orchid unique.A dhr file from the time of manufacture could not be reviewed because it is not been scanned into tungsten yet.Jde confirmed that the lot was released for sale in february 2020.Device history batch null, device history review that no non-conformances occurred during manufacture.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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) 2020, the surgeon was drilling with a 1.0 drill bit and after going through the first cortex, the drill bit broke before penetrating the second cortex.The tip of the fluted drill bit approximately 5 mm was retained in the patient.There was no surgical delay.The procedure was successfully completed.Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 1.0MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/75MM
• 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: 9832889
• Report Number: 2939274-2020-01278
• Device Sequence Number: 13634990
• Product Code: HTW
• UDI-Device Identifier: 10886982075215
• UDI-Public: (01)10886982075215
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: 03.130.100
• Device Catalogue Number: 03.130.100
• Device Lot Number: U354366
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR