MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SLENDER INSERTER; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	CET30131T
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
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.H11 additional narrative: e1: initial reporter is j&j company representative h3, h4, h6 photo investigation the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that slender inserter had unable to assemble & unable to disassemble.The provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the slender inserter would not contribute to the complained device issue.Based on the investigation findings, cause not established and 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 the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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
It was reported during a level 2 acdf procedure on (b)(6) 2024, the slender inserter teeth do not open wide enough to grab the implant cage.Instead, the scrub had to latch one tooth of the inserter into the implant and then leverage the other tooth and an audible click was heard as it snatched the implant.There was no patient complications, the case was completed successfully.This report is for one slender inserter this is report 1 of 1 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.H11 additional narrative: added: d4 (lot number), d9, d10 and h4 corrected: d4 (primary udi number) h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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, h6 photo investigation: the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4) conduit cervical rebranded module.The photo investigation revealed that slender inserter had unable to assemble & unable to disassemble.The provided evidence was not sufficient to confirm the reported event of being unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the slender inserter would not contribute to the complained device issue.Based on the investigation findings, the cause is not established and 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 the 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.H3, h6: product investigation the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found signs of normal use throughout the device.Additionally, was slightly bent from the teeth of part 3 of 5.A functional test was performed.All the device parts were assembled, and the open and close mechanism was actuated but it was impossible to open the teeth completely.The mating device (cet30201t) also returned in this complaint was tried to assemble but the bent condition of the slender inserter caused the malfunction in the assembly process.A dimensional inspection was not performed due the post-manufacturing damage.With the information received and after the investigation it was not possible to determine a potential cause for the issue experienced by the customer.Once the product leaves j&j medtech orthopaedics control, it is unknown what conditions the device is exposed to.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.According to the conduit¿ cervical system instruments the slender insert it's the following: -connect the tube wheel (part 2) to the distal end of the outer tube (part 1).-insert the gripper (part 3) into the proximal end of the outer tube while holding both the outer tube and the tube wheel firmly in place.-insert the gripper (part 3) into the proximal end of the outer tube while holding both the outer tube and the tube wheel firmly in place.-engage the threads of the tube wheel onto the threads of the gripper by turning the tube wheel one full turn clockwise to hold the pieces loosely together.-attach the tail wheel (part 4) to the distal end of the tube wheel.Hold in place while completing the next step.-slide the distal end of the pin with stops (part 5) into the proximal end of the gripper.Align the forks of the proximal end of the pin with the edges of the gripper.-slide the forks of the pin past the tip of the gripper until the pin can¿t go any further.Engage the threads of the tail wheel with the threads of the pin by turning the tail wheel one full turn clockwise.-alternatively, you may use the non-stop pin in place of the pin with stops to complete this step.-turn the tail wheel to change the position of the pin.The overall complaint was confirmed as the observed condition of the slender inserter would have contributed to the complained device issue.Based on the investigation findings, the potential cause is not established, and 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 review (dhr): a review of the receiving inspection (ri) verse alignment device, open, was conducted identifying that lot number was nn166257 released in one batch.¿ batch 1: lot qty of (b)(4) units was released on 15 oct 2021 with no discrepancies.¿ batch 2: lot qty of (b)(4) units was released on 15 oct 2021 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 history review (dhr): 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: SLENDER INSERTER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 19613983
• Report Number: 1526439-2024-01711
• Device Sequence Number: 7097220
• Product Code: ODP
• UDI-Device Identifier: 10705034555713
• UDI-Public: (01)10705034555713(10)NN166257
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210728
• 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,Followup,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: CET30131T
• Device Lot Number: NN166257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 09/24/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 09/13/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPACTOR.
• Patient Sex: Unknown