MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279712570
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in switzerland as follows: it was reported that on (b)(6) 2022, during a scoliosis correction surgery involving multiple viper cfx screws (19) and a single expeduim uniplanar screw.The persuasion and derotation maneuvers were performed onto the cfx screws with viper3d systems and onto the expedium uniplanar screw with the help of a flex clip system.When the ad-hoc derotation was performed, the surgeon final-locked all screws with the appropriate torque-limiting handle.Since this customer already encountered multiple issues where uniplanar screws were not strongly holding on the rod, thus rotating in an axial plane around the rod, the customer checked the attachment stiffness of the uniplanar screw to the rod (after the torque locking).The customer then pushed the flex clip medically and the uniplanar screw consequently turned in an axial plane as already encountered in a couple of other surgeries.This report involves one (1) expedium spine system clip-on red.Dev w/ dovetail 5.5mm.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter address line 1: (b)(6).Initial reporter occupation: reporter is a j&j employee.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.

• Brand Name: EXPEDIUM SPINE SYSTEM CLIP-ON RED. DEV W/ DOVETAIL 5.5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14714206
• Report Number: 1526439-2022-00879
• Device Sequence Number: 14003679
• Product Code: LXH
• UDI-Device Identifier: 10705034198996
• UDI-Public: 10705034198996
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 279712570
• Device Catalogue Number: 279712570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: APPROXIMATOR FC SLEEVE
• Patient Sex: Unknown