MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 SCREW EXTENSION, OPEN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286725300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2022
Type of Reportable Event	Malfunction
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.Reporter is a synthes employee.A review of the receiving inspection (ri) for viper2 screw extension, open was conducted identifying that lot number mi22038 was released in one batch.Batch1: released on 18 april 2012 with no discrepancies.Supplier: micropulse incorporated.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 product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with the viper2 screw extension, open.A dimensional inspection for the viper2 screw extension, open was unable to be performed as it is irrelevant to the reported complaint condition.A functional test could not be performed as the mating device was not returned.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the viper2 screw extension, open was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed the drawings reflecting the current and manufactured revisions were reviewed.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 japan reports an event as follows: it was reported that patient underwent a tlif (l4-5-s) for treating lumbar spinal canal stenosis with viper 2 system on (b)(6) 2022.The surgeon attached an open extender to the screw for reduction.When they tried to deploy a rod, the l5 extender came off.The screw was removed, and it was confirmed that the screwhead had been damaged.The rest of the procedure was completed with replacements without a further issue.This report is for a viper2 screw extension, open.This is report 2 of 2 for (b)(4).

• Brand Name: VIPER2 SCREW EXTENSION, OPEN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 15115369
• Report Number: 1526439-2022-01285
• Device Sequence Number: 14994325
• Product Code: LXH
• UDI-Device Identifier: 10705034214351
• UDI-Public: (01)10705034214351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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
• Device Model Number: 286725300
• Device Catalogue Number: 286725300
• Device Lot Number: MI22038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2012
• 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: 5.5 TI CORT FIX 7X35MM.
• Patient Sex: Unknown