MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CH MIS CANNULATED X-TAB 7X40MM TI; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number	186770040
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes reports an event in (b)(6) as follows: this is report 2 of 2 for (b)(4).It was reported by the customer in japan that a patient underwent a removal procedure on (b)(6) 2022.It was observed that when the surgeon put stress to the screwdriver device for removing the screw device from the hardened bone, the tip of the screwdriver device broke off.According to the report, the core area of the removed screw device was deformed.There was no fragment generated.The procedure was completed less than 30-minute surgical delay.The patient was x-rayed, and it was confirmed that no fragment had been left in the lesion.The surgeon confirmed that the events were triggered by the patient¿s hardened bone.The status of the patient was unknown.No additional information was provided.This report is for (1) mis cannulated x-tab 7x40mm ti device.This complaint involves 2 devices.
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.(b)(4).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.
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.H10 additional narrative: d9 e1 initial reporter address.H3, 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 mis cannulated x-tab 7x40mm ti had the head of the screw deformed due to the tip of it is mating device [t20 driver shaft] is stuck.No other issues were observed.A dimensional inspection was not performed for the mis cannulated x-tab 7x40mm ti due to post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 mis cannulated x-tab 7x40mm ti 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.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: MIS CANNULATED X-TAB 7X40MM TI
• Common Device Name: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14213070
• Report Number: 1526439-2022-00611
• Device Sequence Number: 4435526
• Product Code: MNH
• UDI-Device Identifier: 10705034129662
• UDI-Public: 10705034129662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 186770040
• Device Catalogue Number: 186770040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown