MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT/MINI QC/65MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	310.141
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: gfa, gff, hsz.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.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.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 during the procedure, the tip of the 1.5mm drill bit broke.Fragments were generated and a fragment remained in the patient.There was no surgical delay.The procedure was successfully completed using another drill bit.This report is for one (1) 1.5mm drill bit/mini qc/65mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM DRILL BIT/MINI QC/65MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12468184
• Report Number: 2939274-2021-05411
• Device Sequence Number: 3779546
• Product Code: HWE
• UDI-Device Identifier: 10886982185983
• UDI-Public: 10886982185983
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/17/2021

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: 310.141
• Device Catalogue Number: 310.141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1