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

Catalog Number	286750036
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.H3, h4, h6 photo review the photo investigation revealed that device (b)(6), viper prime palm handle had scratches on the surface and can observe wear and tear condition.And photo did not reveal any evidence to confirm the unable to assemble/disassemble condition.The overall complaint was not confirmed as the observed condition of the device (b)(6), viper prime palm handle would not contribute to the complained device issue.Based on the investigation findings, 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 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 a review of the receiving inspection (ri) for viper prime palm handle was conducted identifying that lot number mf4499504 released in two batches.Batch1: lot qty of (b)(4) units were released apr 1, 2022 with no discrepancies.Batch2: lot qty of (b)(4) units were released may 2, 2022 with no discrepancies.Supplier: metal craft machine & engineering 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 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 canada as follows: it was reported during a spinal fusion procedure on (b)(6), 2023, the nurse was having difficulties inserting and removing the gauge with stylet through the palm handles.The top of the handles are likely to be damaged from the mallet.The handle appeared damaged where there is a silver ring where the inner stylet fits in.The surgery was completed successfully with the t handles found in the set.No surgical delay or patient impact.This report is for viper prime palm handle 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: 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 the viper prime palm handle, exhibits numerous scratches.A functional l test to assess the unable to assemble allegation was not conducted since the rest of the viper prime system was not returned for evaluation.The observed condition was consistent as an end of life indicator for the device.No other issues where identified.A functional test could not be performed as the mating device was not returned.The device exhibits damage consistent with repeated use.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.The overall complaint was unconfirmed as the observed viper prime palm handle would not have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history review (dhr): a review of the receiving inspection (ri) for viper prime palm handle was conducted identifying that lot number mf4499504 released in two batches.Batch1: lot qty of (b)(4) units were released apr 1, 2022 with no discrepancies.Batch2: lot qty of (b)(4) units were released may 2, 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 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.Mer.D10: date of concomitant therapy is 11/30/2023.

• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18384519
• Report Number: 1526439-2023-02595
• Device Sequence Number: 14143086
• Product Code: OLO
• UDI-Device Identifier: 10705034507637
• UDI-Public: (01)10705034507637
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: MF4499504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; VIPER PRIME PALM HANDLE
• Patient Sex: Unknown