MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: mni, kwq, kwp, mnh, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.Initial reporter facility name: (b)(6) hospital.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure the screw broke.The surgeon removed the broken piece.The surgeon connected two screws.Patient outcome was unknown.This report involves one (1) expedium verse spine system polyaxial screw 5.5 6.0 x 45mm.This is report 1 of 1 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.Unknown lot, therefore, a dhr review could not be performed.Photo investigation: the device was not returned.A photo-investigation was performed on the images.A broken condition was not confirmed.Some deformation to the top of the screw head was noted, but thread damage could not be confirmed in the provided image.No other issues were observed.No device identifiers were visible.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.Conclusion: the complaint of broken was not confirmed during investigation.Deformation was noted to the screw head.No device malfunction, damage, or defect was noted during investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.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
The surgeon connected two screws but could not use the other four.Due to breakage of the rods including the synapse during connecting he couldn¿t use other the one (1), it was not enough.Concomitant device reported.Unknown transverse connector (product# unknown, lot# unknown, qty 2) this is report 1 of 2 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.B5 d9 h3, h6: the dhr of product code: 199721645 lot : 265957 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 10.12.2019 qty: (b)(4).Visual inspection: the 5.5 exp verse screw 6.0 x 45 (p/n: 199721645, lot #: 265957) was returned and received at us customer quality (cq).Upon visual inspection, the complaint device showed the head of the screw was locked in the monoaxial position and the reduction tabs were broken.Per the system guide, the removal of expedium verse screw reduction tabs at the completion of the procedure using tab remover and the polyaxial screw converts to a monoaxial screw upon tightening of the set screw.The system guide indicates that exceeding the system torque may result in failure of the implant.Upon loosening of the set screw, the screw head should become mobile again.Functional test: a functional assessment was performed on the complaint device.The head of the screw was unable to be moved from the received position.The complaint was able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed expedium verse - 4.35mm / 8mm poly screw assembly no design issues or discrepancies were identified.Complaint confirmed? no investigation conclusion: this complaint was not confirmed as per the system guide, the removal of expedium verse screw reduction tabs at the completion of the procedure using tab remover.A possible root cause for the screw head unable to move could be due to over-torqueing of the set screws, however no definitive root cause could be identified.There was no indication that a design or manufacturing issue contributed to the complaint.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: EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11131603
• Report Number: 1526439-2021-00103
• Device Sequence Number: 3248344
• Product Code: NKB
• UDI-Device Identifier: 10705034442273
• UDI-Public: (01)10705034442273
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/10/2020

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 Model Number: 199721645
• Device Catalogue Number: 199721645
• Device Lot Number: 265957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/14/2021; 01/18/2021; 12/10/2020; 03/05/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/15/2021; 02/08/2021; 03/04/2021; 03/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN TRANSVERSE CONNECTOR