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

Catalog Number	286750036
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Patient underwent mis degenerative case.During assembly of the viper prime navigated screwdriver, the scrub nurse noted that the end cap of the palm handle was deformed in such a way that the stylet holder could not be inserted through the palm handle.All handles are deformed.It seems that striking the caps on the handles causes them to deform, even though these caps are specifically designed for this purpose.Surgery could be completed by changing the assembly sequence, so no issued occurred during surgery.There was no patient consequence.There was no delay in surgery.
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.H11 additional narrative: added: d9.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found evidence of repeated use wear.Several marks from hammering were noted over the surface of the handle core component.A slight deformation was noted due to usage.A complete functional test can not be performed due mating device not returned, however due to the condition of the sample it is possible a functionality issue may be present.The observed conditions were consistent with a random component failure that may have been caused by exposure to unintended forces in combination with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the viper prime palm handle would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 palm handle was conducted identifying that lot number mf4502508 released in one batch.¿ batch1: lot qty of (b)(4) units were released on may 20, 2022 with no discrepancies ¿ batch2: lot qty of (b)(4) units are released on may 11, 2022 with no discrepancies ¿ batch3: lot qty of (b)(4) units were released on aug 8, 2022 with no discrepancies.Supplier: (b)(4).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.Device history batch: null.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 PALM HANDLE
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 24083559
• Report Number: 1526439-2026-00041
• Device Sequence Number: 17636315
• Product Code: OLO
• UDI-Device Identifier: 10705034507637
• UDI-Public: (01)10705034507637(10)MF4502508
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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 Catalogue Number: 286750036
• Device Lot Number: MF4502508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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
• Patient Sex: Unknown