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

Model Number	286750035
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 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 the (b)(6) as follows: it was reported that on (b)(6) 2021, during the assembly of the viper prime inserter, the scrub team could not introduce the stylet gauge into the top of the instrument.The issue was due to repetitive impact damage to the top of both t-handles.The stylet gauge therefore needed to be introduced without the handle in-situ, with the handle then applied retrospectively.This was done for both inserters.There was no impact or delay to the procedure.This report involves one (1) viper prime t-handle.This is report 2 of 4 for pc (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: b5 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
During assembly of the viper prime inserter, they were unable to introduce the stylet gauge into the top of the instrument due to repetitive impact damage to the top of both t-handles.The stylet gauge then needed to be introduced without the handle in-situ, with the handle then applied retrospectively.This was done for both inserters.No impact or delay to the procedure.

• Brand Name: VIPER PRIME T-HANDLE
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12032159
• Report Number: 1526439-2021-01259
• Device Sequence Number: 17137650
• Product Code: OLO
• UDI-Device Identifier: 10705034507620
• UDI-Public: (01)10705034507620
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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: PRIME STYLET DEPTH ADJUSTOR; UNKNOWN INSERTER SHAFT; UNKNOWN RED STYLET CONTROL HANDLE; VIPER PRIME T-HANDLE