MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	186715000
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient underwent spina fusion on (b)(6) 2024.While inserting the innie, the thread in the screw head broke and the innie could not be inserted anymore.Surgeon exchange the screw.Procedure was completed successfully with a twenty minute delay.There was no patient consequence.Three screws were returned for manufacturer investigation.This report is for a mis single inner setscrew.This is report 3 of 3 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.Additional narrative: d2: additional procodes: kwp, kwq, mnh, mni, osh.D4: udi: the manufacturing date is currently not available.Therefore, the full udi is currently not available.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H11 additional narrative: d4: expiration date h3, h4, h6: a manufacturing record evaluation was performed for the finished device product code:186715000s lot no:375410 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 29-jun-2023 manufacturing site:jabil le locle expiry date:31-may-2028 the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found to be broken from the threads.The reported allegation can be confirmed.The broken fragment was not returned for evaluation.No other defect was found.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the mis single inner setscw would contribute to the complained device issue.Based on the investigation findings, 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 reported 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.Corrected data: d4:udi 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 SINGLE INNER SETSCW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19893804
• Report Number: 1526439-2024-01986
• Device Sequence Number: 7778373
• Product Code: NKB
• UDI-Device Identifier: 10705034121192
• UDI-Public: (01)10705034121192(11)230629(17)280531(10)375410
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160904
• 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

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: 186715000
• Device Lot Number: 375410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown