MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD-480MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186789480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: on (b)(6) 2020 the patient underwent an unknown procedure for treating the 3rd lumbar spine fracture.The viper system was applied.No issue was revealed during medical follow-ups.On (b)(6) 2022 the patient underwent the removal procedure.The reasons for the revision procedure was because the vertebral fracture (l3) showed recovery since the primary procedure.So they came to a conclusion that spinal instrumentation is no longer needed for the patient, and the implants should be extracted.When the rod in question was removed, it was found that the rod had broken off.The rod in question was located beneath a screw (l2 left).This is report 1 of 1 for (b)(4).This report is for a viper rod.
Additional Manufacturer Narrative
Additional narrative: additional code osh, kwp, mnh, nkb, mni.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the preoperative images found evidence of breakage of the viper2 straight rod-480mm located beneath the screw placed left to the lumbar spine.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 viper2 straight rod-480mm.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 code available is for revision surgery.Device history: a review of the receiving inspection (ri) for viper2 straight rod-480mm was conducted identifying that lot number tbabxx was released in one batches. batch1: lot qty of (b)(4) units were released on 14 jan 2020 with no discrepancies.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 ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 availorm is left blank.Pply, the section/field of the form is left blank.H10 additional narrative: e1 h3, h6: a manufacturing record evaluation was performed for the finished device product code: 186789480.Lot: tbabxx.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: september 17, 2019.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 viper2 straight rod-480mm was cut.Two broken fragments were returned.No other product problems were identified.No dimensional inspection was performed due to post-manufacturing damage.Complaint relevant dimensions cannot be taken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.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 viper2 straight rod-480mm would not 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.Drawing/specifications reviewed current and manufactured revisions were reviewed.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.D9 h4.

• Brand Name: VIPER2 STRAIGHT ROD-480MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14084075
• Report Number: 1526439-2022-00553
• Device Sequence Number: 20152634
• Product Code: KWQ
• UDI-Device Identifier: 10705034133522
• UDI-Public: (01)10705034133522
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 04/12/2022

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 Model Number: 186789480
• Device Catalogue Number: 186789480
• Device Lot Number: TBABXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - LOCKING/SET SCREWS: VIPER; UNK - SCREWS: VIPER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown