MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN.; DRIVER, PROSTHESIS

Model Number	286720000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: initial reporter facility: (b)(6) hospital.E3: reporter is a j&j employee.H3, h4, h6: 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 synthese reports an event in russia as follows: it was reported that during surgery on (b)(6) 2023, the screwdriver from the viper 2 broke, and the screw could not be implanted, possibly due to a problem with the screwdriver.The screw was deformed.The set of products was issued by orthokit.There were no casualties.This report involves one viper system poly screwdriver shaft, cann.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Investigation summary: the photo was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that poly scw driver shft, cannultd was not clearly visible, since only the complete section device was observed, the picture does not provide enough evidence to confirm the alleged reported condition.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for poly scw driver shft, cannultd.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation cannot be performed due to lot number being unknown.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.
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 information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The procedure was completed successfully with no surgical delay.There was no adverse patient impact.

• Brand Name: VIPER SYSTEM POLY SCREWDRIVER SHAFT, CANN.
• Common Device Name: DRIVER, PROSTHESIS
• 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: 16945775
• Report Number: 1526439-2023-00868
• Device Sequence Number: 16684840
• Product Code: HWR
• UDI-Device Identifier: 10705034214177
• UDI-Public: (01)10705034214177
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 286720000
• Device Catalogue Number: 286720000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 06/09/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 05/22/2023; 06/29/2023
• 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: MIS CANN POLY SCW 6X50MM,TI
• Patient Sex: Unknown