MAUDE Adverse Event Report: VIPER PRIME CFXFEN XTAB 6X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186760450S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwp, kwq.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 (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the viper prime screw could not be loosened from the viper prime inserter shaft.The procedure was completed using another screw.There was a surgical delay of four (4) minutes.There was no patient consequence.This report is for one (1) viper prime cfxfn xtb 6x50mm s.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.H3, h4, h6- the viper prime cfxfen xtab 6x50mm (part# 186760450, lot# tbagvq) was returned and received at us cq.Upon visual inspection, no issues were observed with the device.The complaint condition cannot be confirmed for the viper prime cfxfen xtab 6x50mm (part# 186760450, lot# tbagvq) as the returned devices functioned as intended.A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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 the dhr of product code: 186760450s.Lot : tbagvq was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 28.06.2021.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 CFXFEN XTAB 6X50MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• MDR Report Key: 12434634
• Report Number: 1526439-2021-01845
• Device Sequence Number: 3383167
• Product Code: NKB
• UDI-Device Identifier: 10705034530109
• UDI-Public: 10705034530109
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170543
• 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): 08/09/2021

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: 186760450S
• Device Catalogue Number: 186760450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARRIER.; UNKNOWN DRIVE TUBE.; UNKNOWN RED STYLET CONTROL HANDLE.; VIPER PRIME INSERTER SHAFT.