MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME T-HANDLE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286750035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the impaction of the viper prime screwdriver was being used to introduce the stylet and at that time the piece or black t-handle broke a little, presenting a fissure.The piece was replaced by another.Procedure was successfully completed.This report is for viper prime t-handle.This is report 1 of 1 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.H10 additional narrative: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.
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.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 further reported that there were no fragments generated during the procedure.There was no delay in the surgery and patient outcome is reported as satisfactory.
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.H3, h4, h6- the complaint device viper prime t-handle was returned to cq west chester for investigation.Upon visual inspection, the handle was found broken at the center.The device had scratches and impaction marks all over the handle.The circular handle core was discolored and had wear associated with usage.No other issues were identified.The t-handle was broken during surgery, a definitive root cause cannot be identified from the available information.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot =a review of the receiving inspection (ri) for viper prime t-handle was conducted identifying that lot number mf4376205 was released in a single batch.Batch1: lot qty of units were released on 08 aug 2019 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: VIPER PRIME T-HANDLE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11748425
• Report Number: 1526439-2021-00822
• Device Sequence Number: 4417861
• Product Code: OLO
• UDI-Device Identifier: 10705034507620
• UDI-Public: (01)10705034507620
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K170937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/06/2021

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: 286750035
• Device Catalogue Number: 286750035
• Device Lot Number: MF4376205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 06/28/2021; 09/20/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/26/2021; 06/28/2021; 10/04/2021
• 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 STYLET