MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE COUNTER TORQUE HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	299704255
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a posterior thoracolumbar fusion at th10-l2 treating traumatic injury on (b)(6) 2020, the nurse tried to attach a facilitator to the torque handle.When she pressed the button of the handle, her glove stuck in the button.She connected the facilitator in other ways, and the procedure was completed without further issue.There was no surgical delay.No further information is available.Concomitant device reported: unknown facilitator (part # unknown, lot # unknown, quantity 1).This report is for one (1) verse counter torque handle.This is report 1 of 1 for (b)(4).

• Brand Name: VERSE COUNTER TORQUE HANDLE
• 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: 10770502
• Report Number: 1526439-2020-02071
• Device Sequence Number: 4011076
• Product Code: LXH
• UDI-Device Identifier: 10705034467474
• UDI-Public: (01)10705034467474
• 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): 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 299704255
• Device Catalogue Number: 299704255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN FACILITATOR