MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 1.45 DIA GUIDEWIRE, BLU; MISC ORTHO SURGICAL INSTR

Model Number	286705220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent for an unknown surgery.During the surgery, when the screw insertion was checked with the c-arm, the chipped guide wire (about 5 mm long) was found near the screw tip.When the removed guide wire was checked, it was confirmed that the guide wire's tip had been broke and lost.The surgeon decided to leave the fragment in the patient's body and completed the procedure.The patient outcome was unknown.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown ).This complaint involves one (1) device.This report is for (1) viper2 1.45 dia guidewire, blu.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER2 1.45 DIA GUIDEWIRE, BLU
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10376255
• Report Number: 1526439-2020-01444
• Device Sequence Number: 19605968
• Product Code: LXH
• UDI-Device Identifier: 10705034213682
• UDI-Public: (01)10705034213682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 286705220
• Device Catalogue Number: 286705220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 08/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR