MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 50MM; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Catalog Number	186727750
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2024
Type of Reportable Event	Serious Injury
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: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1 initial reporter address line 1: klinikum pasing verwaltung steinerweg 5.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on june 14, 2024, the tulip disconnected from screw head in sclerotic bone even after tapping.They tried to remove the screw and extend the construct to an additional level.The screw remains in the patient.There was a surgical delay of twenty (20) minutes.The procedure was completed successfully.This report involves one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 7 x 50mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
Additional information received states that the patient has the screw in body and received a one additional level of fusion.Surgery was finished and patient alive and no other adverse event.
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: b5 event description added.D9 date device returned to manufacturer added.H3, h4, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that only the top notch was returned for analysis.Damage was observed at the bottom, where the screw head supposed to be.Based on the condition of the returned device it is possible to confirm the reported event.However, it remains unknown if fragments or body screw remained inside patient body.A complete potential cause for the observed condition cannot be fully established with available information.Properly handling and attention to the approved use of the device diminishes the risk of failure.Viper cortical fix fenestrated screw system surgical technique was reviewed and the following relevant statement was found at page 5: align the tabs of the alignment sleeve with the rod slot in the screw head, ensuring that the soft tissue does not impinge on the connection of the alignment sleeve to the screw head.Thread the assembled alignment guide into the screw head.This will align the screw shank to the screw head.Confirm that the alignment device is fully seated by checking that it is flush with the top of the alignment sleeve when fully threaded into the screw head.Precaution: the alignment guide must be used for each screw intended for cement augmentation.Without the alignment guide, there is a potential risk of cannula breakage.Use of the alignment guide will prevent undue stress from being applied to the cannula.A dimensional inspection was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the mis ti cfx fen poly 7x50 would contribute to the complained device issue.Based on the investigation findings, 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.Device history review (dhr): a manufacturing record evaluation was performed for the finished device product code: 186727750.Lot number: 382875.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 20-oct-2023.Manufacturing site: jabil le locle.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 50MM
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 19794193
• Report Number: 1526439-2024-01880
• Device Sequence Number: 7252495
• Product Code: PML
• UDI-Device Identifier: 10705034282688
• UDI-Public: (01)10705034282688(11)231020(10)382875
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160879
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 186727750
• Device Lot Number: 382875
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male