MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 LORDOTIC ROD-65MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186788065
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.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
It was reported that on (b)(6) 2021, surgeon was performing l4-s1 percutaneous fusion with viper prime.Five screws were implanted as intended.When it came time to locking in the rod connecting the screws, he struggled to capture the rod with the locking caps due to the rod not being seated low enough for the caps to catch on the threads of the prime screw extended tab.He began to try to force the rod lower so that he could capture it with the locking caps, but he could not get it low enough to the cap to catch.During this struggle, one of the extended tabs broke off making it even more difficult to be able to capture the rod.The broken tab was removed without incident.He continued to try but couldn¿t get the rod low enough to engage multiple locking caps on either side.So, the surgeon ended up having to remove all 5 screws and replace them with another system.The broken extended tab certainly contributed to the frustration and the decision to abandon the system for this patient.The surgeon reasoned that if he can¿t put more force on the rod to be able to capture it without breaking the tabs, or if there is not another reduction tool available for viper prime, then he can¿t complete the surgery.After changing systems, the surgery was completed and l4-s1 fusion performed.There was a thirty (30) minute surgical delay due to reported event.Procedure was successfully completed.There was no patient harm/consequence.Patient outcome is reported as fine.This report is for one (1) viper2 lordotic rod-65mm.This is report 2 of 2 for complaint (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: h6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) were reviewed, and the complaint condition could not be confirmed as no defect was identified from the returned images.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: VIPER2 LORDOTIC ROD-65MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11703739
• Report Number: 1526439-2021-00763
• Device Sequence Number: 3659410
• Product Code: NKB
• UDI-Device Identifier: 10705034131788
• UDI-Public: (01)10705034131788
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 186788065
• Device Catalogue Number: 186788065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 05/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS SINGLE INNER SETSCW; UNKNOWN TIGHTENER; VIPER PRIME CFXFEN XTAB 5X40MM; VIPER PRIME CFXFEN XTAB 6X35MM; VIPER PRIME CFXFEN XTAB 6X40MM; VIPER PRIME CFXFEN XTAB 6X40MM
• Patient Age: 71 YR
• Patient Weight: 88