MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH AO HANDLE SMALL W SWIVEL; MISC ORTHO SURGICAL INSTR

Model Number	2020-00-500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Nerve Damage (1979); Injury (2348)
Date of Event	07/29/2020
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.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) 2020 the surgeon doing a posterior cervical fusion, while finishing up the case and beginning to lock the symphony rods in place from c3-t1.Nurse handed the first set screw driver the driver shaft fell from the handle that the surgeon was holding and landed in the incision on the back of the patients neck landing directly on his spinal cord which was fully exposed from the laminectomy that was completed to decompress the spinal cord.Intraoperative neurophysiologic monitoring (ionm) of the patient's neuro signals throughout the case recorded an immediate deficit to that area of the spinal cord.Motors were performed regularly throughout the remainder of the case and feedback was provided to the surgeon that signals were improving toward baseline levels.Procedure was completed with no surgical delay.The patient status/outcome is unknown.Concomitant devices: unknown setscrew (part# unknown, lot# unknown, quantity unknown).Unknown rods (part# unknown, lot# unknown, quantity unknown).Unknown handle (part# unknown, lot# unknown, quantity unknown).This report is for one (1) ao handle small w swivel.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.

• Brand Name: AO HANDLE SMALL W SWIVEL
• 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: 10450833
• Report Number: 1526439-2020-01533
• Device Sequence Number: 3558936
• Product Code: LXH
• UDI-Device Identifier: 10705034532622
• UDI-Public: 10705034532622
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2020-00-500
• Device Catalogue Number: 202000500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: UNK - HANDLES; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention