MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 7 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179712750
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that it was not possible to screw the innie into the screw head.After removing the screw, it was discovered that there was damage to the thread in the screw head.There was a five (5) minute surgical delay while the defective screw was replaced.The procedure was completed successfully.Concomitant device reported: unknown innie (part# unknown, lot# unknown, quantity unknown).This report is for one (1) si polyaxl screw 7 x 50mm.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.The dhr of product code: 179712750, lot : 309927 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: may 20, 2021.Visual inspection: the complaint device expedium screw (product code: 179712750, lot number: 309927) was returned to customer quality (cq) west chester for investigation.The opening for the single innie screw appeared damaged and stripped.No other issues were identified.Functional test: a functional test could not be performed as a mating part was not returned with the screw.Can the complaint be replicated with the returned device(s)? no, the complaint cannot be replicated as a functional test was not performed.Dimensional inspection: a dimensional inspection could not be performed due to the design of the device.Measuring device used: caliper.Document/specification review: based on the date of manufacture, the current and manufactured version of drawing were reviewed.Complaint confirmed: yes, the complaint condition of stripped can be confirmed during physical device investigation.Conclusion: the complaint condition of will not lock could not be confirmed during investigation but the device appeared stripped and damaged.A definitive assignable root cause could not be determined from the available information.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.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.

• Brand Name: SI POLYAXL SCREW 7 X 50MM
• 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12673104
• Report Number: 1526439-2021-02230
• Device Sequence Number: 19908183
• Product Code: NKB
• UDI-Device Identifier: 10705034067919
• UDI-Public: 10705034067919
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2021

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: 179712750
• Device Catalogue Number: 179712750
• Device Lot Number: 309927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 11/23/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/18/2021; 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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: UNKNOWN LOCKING/SET SCREWS.; UNKNOWN LOCKING/SET SCREWS
• Patient Sex: Unknown