MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT; MISC ORTHO SURGICAL INSTR

Model Number	03.010.079
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/16/2021
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 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 preventative 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) 2021, the drill stop for 4.5mm /6.5mm stepped drill bit in the femoral recon nail tray broke off in the femoral head of the patient intraoperatively.Tried to retrieve the broken bit with the pituitary.There were a few extra x-rays taken when attempting to retrieve the broken piece.The broken piece was left in the femoral head.There were 10 minutes of surgical delay.The procedure successfully completed.No patient consequence.This complaint involves one (1) device.This report is for (1) drill stop for 4.5mm/6.5mm stepped drill bit.This is report 1 of 1 (b)(4).

• Brand Name: DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11281682
• Report Number: 2939274-2021-00686
• Device Sequence Number: 17019259
• Product Code: LXH
• UDI-Device Identifier: 10886982067494
• UDI-Public: (01)10886982067494
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2021

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: 03.010.079
• Device Catalogue Number: 03.010.079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2021
• Initial Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention