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

Model Number	199721645
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product codes: mni, kwq, kwp, mnh, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a depuy sales representative 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 portugal reports an event as follows: it was reported during a verse revision surgery, when the doctor tried to mobilize the head of the screw, it was not possible because it was blocked; even when using the head adjuster instrument to mobilize the head.It was necessary to take out the two screws in order to place the rod.The procedure was completed successfully with a ten (10) minute delay and consequence to the patient.It was noted the revision procedure was necessary due to one of the screws not being in the right place.The original procedure occurred about a month prior in november.This report is for an expedium verse screw.This is report 2 of 2 for (b)(4).This complaint captures the issues during the revision procedure.The need for the revision procedure is captured in related complaint (b)(4).
Additional Manufacturer Narrative
Additional product codes: mni, kwq, kwp, mnh, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a depuy sales representative 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 (b)(4) reports an event as follows: it was reported during a verse revision surgery, when the doctor tried to mobilize the head of the screw, it was not possible because it was blocked; even when using the head adjuster instrument to mobilize the head.It was necessary to take out the two screws in order to place the rod.The procedure was completed successfully with a ten (10) minute delay and consequence to the patient.It was noted the revision procedure was necessary due to one of the screws not being in the right place.The original procedure occurred about a month prior in november.This report is for an expedium verse screw.This is report 2 of 2 for (b)(4).This complaint captures the issues during the revision procedure.The need for the revision procedure is captured in related complaint (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.H3, h6: a product investigation was conducted.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 5.5 exp verse screw 6.0 x 45 did not showed any cosmetic anomaly.A dimensional inspection was not performed due to the inaccessibility of the internal components without destruction of the device.A functional test was performed by hand and the screw's head was noted jammed and not able to rotate/move.The complaint condition was able to be replicated.A manufacturing record evaluation was performed for the finished device [283749] number, and no non-conformances were identified.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 5.5 exp verse screw 6.0 x 45 would 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.A manufacturing record evaluation was performed for the finished device.Product code: 199721645.Lot number: 283749.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 10.07.2020.Qty: (b)(4).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: 5.5 EXP VERSE SCREW 6.0 X 45
• 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
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13235737
• Report Number: 1526439-2022-00078
• Device Sequence Number: 19903696
• Product Code: NKB
• UDI-Device Identifier: 10705034442273
• UDI-Public: (01)10705034442273
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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 Model Number: 199721645
• Device Catalogue Number: 199721645
• Device Lot Number: 283749
• 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: 12/17/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2020
• 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: 5.5 EXP VERSE SCREW 6.0 X 45
• Patient Sex: Male