MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 1.45MM NITINOL GUIDEWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286705320
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional 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.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) 2022, during spinal fusion surgery, a piece of a guide wire broke off while placing a screw and stayed in the patient.There was no surgical delay.The procedure was successfully completed.The fragments could not be removed easily by the surgeon as there was no way to retrieve it.There was no patient consequences.The procedure was successfully completed.This report is for one (1) 1.45mm nitinol guidewire blunt.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 1.45MM NITINOL GUIDEWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 14047369
• Report Number: 1526439-2022-00538
• Device Sequence Number: 17370379
• Product Code: LXH
• UDI-Device Identifier: 10705034507859
• UDI-Public: (01)10705034507859
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 286705320
• Device Catalogue Number: 286705320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown