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

Model Number 286750036

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/26/2022

Event Type  malfunction  

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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 Description

Device report from synthes reports an event in canada as follows: it was reported that on (b)(6) 2022, it was noticed that the palm handles were damaged on the top.Once the handle was inserted, the gauge could not be easily inserted due to the damaged metal on the top of the palm handle.Also, the targeting forceps were old and damaged at the tip, where the black rubber material is wearing off and starting to peel.There was no patient consequence as a result of these events.No further details are available.This report involves one viper prime palm handle.This is report 2 of 8 for (b)(4).

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: d4, h4 a review of the receiving inspection (ri) for viper prime palm handle was conducted identifying that lot number mf4422502 was released in one batch.¿ batch 1: lot qty of 137 units were released on 15 dec 2020 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.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, p/n: 286750036, 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.After a visual inspection per procedure, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of viper prime palm handle, p/n: 286750036 would 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER PRIME PALM HANDLE
• Type of Device: 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: 15617009
• MDR Text Key: 302579409
• Report Number: 1526439-2022-01812
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507637
• UDI-Public: 10705034507637
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 286750036
• Device Catalogue Number: 286750036
• Device Lot Number: MF4422502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PIPELINE LS DILATOR HOLDER; PIPELINE LS DILATOR HOLDER; PIPELINE LS DILATOR HOLDER; PIPELINE LS DILATOR HOLDER; VIPER PRIME PALM HANDLE; VIPER PRIME PALM HANDLE; VIPER PRIME PALM HANDLE