MAUDE Adverse Event Report: DEPUY SPINE INC ISOLA SPINE SYSTEM ROD CUTTER; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number 205027

Device Problems Detachment of Device or Device Component (2907); Illegible Information (4050)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported during a spinal fusion procedure on (b)(6) 2023 there was an issue with a rod cutter.The surgeon was using the isola side rod cutter and as he was closing the cutter arms the mouth of the cutter came apart.Another set was opened and he used that one to cut the rod.It is unknown if there was surgical delay.No known patient consequences.Concomitant device reported: expedium core instruments - surgeon (part# znausp9200; lot# unknown; quantity: unknown).This report is for one isola spine system rod cutter 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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6 investigation summary the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment visual analysis of the photo revealed that is rod side cutter had the jaw of the rod cutter broken, fragment was not observed in the visual evidence provided, the device was rusted on all surface and the two rivets holding the plates and mouth of the rod cutter together were missing.These rivets consist of two separate ends.One side is hollow, which allows for the second, smaller diameter rivet to be inserted into the first.These two rivets appear to be welded together and the welds have broken, resulting in the two plates fell apart of the mouth of the rod cutter.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for is rod side cutter.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Device history a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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.

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 is rod side cutter had the two plates and four rivets fallen apart, all of the components were returned for evaluation in a separate bag.It is possible that the rivets were loose prior to usage, and fell from the device while applying force to cut the rod.Additionally, the jaws of the cutter are broken and chipped, fragments were not returned.The broken condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As the device information such as product code and lot number are located at one of the plates, the etch being unable to read cannot be confirmed.The observed worn and nicked condition was identified as an end of life indicator; damage consistent 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 for the is rod side cutter was unable to be performed due to post manufacturing damage.Functional test was not performed since it is not applicable to complaint condition.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 the is rod side cutter would contribute 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 required.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 review (dhr): a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.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.

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: h4: updated device history a review of the receiving inspection (ri) for is rod side cutter was conducted identifying that lot number hm43311 was released in one batch.Batch1: lot qty of (b)(4) units were released on 31 oct 2016 with no discrepancies.Supplier : depuy : precision engineered products holmed llc 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.

• Brand Name: ISOLA SPINE SYSTEM ROD CUTTER
• Type of Device: INSTRUMENT, CUTTING, ORTHOPEDIC
• 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: 17423939
• MDR Text Key: 320032518
• Report Number: 1526439-2023-01395
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10705034001258
• UDI-Public: 10705034001258
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• 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: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205027
• Device Lot Number: HM43311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXPEDIUM CORE INSTRUMENTS - DR (B)(6).; UNKNOWN CASES, TRAYS, MODULES