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

Model Number 205030

Device Problems Break (1069); Device Slipped (1584); Use of Device Problem (1670)

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

Event Date 02/08/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes reports an event in australia as follows: it was reported that on (b)(6) 2023 during a lumbar fusion procedure using a loan expedium set, when the table top rod cutter was opened onto the sterile field, it was noted to pivot sideways near the cutting section where it should not pivot side ways.This cutter was placed to the side and not used.A second cutter was opened and used instead.After the case it was noticed that there was a screw missing from underneath the cutter which has caused it to come loose and pivot.The procedure was successfully completed with no surgical delay.There was no patient consequence.This report is for one (1) isola system table top rod cutter.This is report 1 of 1 for complaint (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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Photo investigation: the pictures were returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the involved device pictures.Visual analysis of the pictures revealed that the is table top rod cutter is missing one of the screws (2050-30-10) that support the arm/body assembly, which appears misaligned.A functional test cannot be performed since the device was not returned.However, the reported loose/misalignment condition is due to the missing screw.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 the is table top rod 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.No lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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: 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.A review of the receiving inspection (ri) for is table top rod cutter was conducted identifying that lot number sr252080 was released in one batch.Batch 1: lot qty of (b)(4) units were released on 25 mar 2020 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.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 table top rod cutter had the screws which attach the body and base missing, this condition could have contributed to the device disassembling and falling apart.With the provided information, it is not possible to establish a root cause for the missing components.A dimensional inspection for the is table top rod cutter was not performed as it is not applicable to the complaint condition.A functional test was unable to be performed as the device was received misassembled, however, functional issues are most likely due to the screws missing 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 table top rod cutter would contribute to the complained device issue.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ISOLA SYSTEM TABLE TOP 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 ; 8472871282
• MDR Report Key: 16456342
• MDR Text Key: 310438570
• Report Number: 1526439-2023-00367
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10705034001289
• UDI-Public: (01)10705034001289
• 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: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 205030
• Device Catalogue Number: 205030
• Device Lot Number: SR252080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2020
• 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