MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 186727745

Device Problems Break (1069); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in austria as follows: it was reported that the patient underwent a revision surgery on (b)(6) 2023 due to a broken expedium cfx screw that was implanted in s1 as a part of a long-distance degenerative treatment.During the surgery, it was determined that further screws had cooed into the pedicles.These had to be replaced with new expedium cfx implants.When removing the loosened implants with the expedium polydriver, the screw heads broke off.When implanting the revision screws, an expedium polydriver broke off at the drive of the screwdriver in the shaft head of the screw despite proper handling.Additionally, two awls were bent.This report involves one viper system fenestrated cortical fix polyaxial screw 5.5 x 7 x 45mm.This is report 4 of 7 for (b)(4).

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D2b: additional device product codes: pml.H3, h4, h6: 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.

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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device visual analysis of the photograph provided was not able to found the mis ti cfx fen poly 7x45 associated with this complaint.Therefore the investigation could not draw any conclusions about the reported event without the device to examine.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 unconfirmed for the [mis ti cfx fen poly 7x45].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.

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.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 Description

1st/2nd (b)(6) 2022 (implantation of the cfx/ilium screws.A loose screwdriver attachment that remained in the s1 screw during the procedure on (b)(6) 2022.For revision, procedure was completed successfully with no surgical delay.Non-union at l5/s1 was reported.No fragments were left behind in the patient due to broken screws.Intervention was required to remove all fragments.Patient status was noted as a decrease of pain medication and a discharge to contemporary nursery home no further follow up.For this complaint we will be reporting the post-operative and intra-operative event on (b)(6).The reported screws had malfunctions during post-operative and intra-operative phases of care.

• Brand Name: VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 7 X 45MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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 ; SZ ; 3035526892
• MDR Report Key: 17412411
• MDR Text Key: 319918388
• Report Number: 1526439-2023-01379
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034282671
• UDI-Public: (01)10705034282671
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K160879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 186727745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/14/2023; 09/08/2023
• Supplement Dates FDA Received: 08/28/2023; 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MIS TI CFX FEN POLY 7X45; MIS TI CFX FEN POLY 7X45; MIS TI CFX FEN POLY 7X45; MIS TI CFX FEN POLY 7X50; MIS TI CFX FEN POLY 7X50; XPDM PEDICLE PROBE, STRAIGHT; XPDM QUICK-CON SI POLY SCWDRVR; XPDM THORACIC PEDICLE PRB, ST
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 76 KG