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	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the when nurse was setting up viper prime screwdrivers with palm handles ang gauges, it was noticed that the handles are damaged where the gauge fits in.The top of the handles are impacted where the gauge no longer screws in.Therefore the nurse had to change the handles.There was no patient impact and no surgical delays.The procedure was successfully completed.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Additional narrative: h3, h6: photo investigation: the product was not returned to medtech orthopaedics, however photos were provided for review.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.The provided evidence was not sufficient to confirm the reported event of inability to assemble.Device interaction issues cannot be evaluated through a photo investigation.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.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 medtech orthopaedics 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.A review of the receiving inspection (ri) for viper prime palm handle was conducted identifying that lot number mf4510206 was released in three batches.Batch1: lot qty of (b)(4) units were released on aug 1, 2022, with no discrepancies.Batch2: lot qty of (b)(4) units were released on sep 20, 2022, with no discrepancies.Batch3: lot qty of (b)(4) units were released on oct 13, 2022, with no discrepancies.Supplier: (b)(6).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.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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 20856502
• Report Number: 1526439-2024-02926
• Device Sequence Number: 15669763
• Product Code: OLO
• UDI-Device Identifier: 10705034507637
• UDI-Public: (01)10705034507637(10)MF4510206
• 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: 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
• Operator of Device: Health Professional
• Device Catalogue Number: 286750036
• Device Lot Number: MF4510206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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