MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 X 18MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186850018
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes employee.The dhr of product code: 186850018.Lot : atpb2c was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: february 25, 2016.Visual inspection: the sky variable s-d scw 18mm ti (part# 186850018, lot# atpb2c, qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the screw is broken at the shaft.No other issues were observed with the device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to the design of the device.Document/specification review: the following drawing(s) was reviewed: 4.0mm variable self-drilling screw, 10-20mm, prius acp: current and manufactured revisions.No design issues or discrepancies were found during this investigation.Complaint confirmed? yes.Investigation conclusion: the complaint is confirmed for the sky variable s-d scw 18mm ti (part# 186850018, lot# atpb2c, qty# 1).A definitive root cause could not be identified for the reported issue with the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, 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.
Event or Problem Description
It was reported that on an unknown date, the device was received for investigation.The device appears to be broken.This report involves 1 skyline anterior cervical plate system variable self-drilling screw 4.0 x 18mm.This is report 1 of 1 for (b)(4).

• Brand Name: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 X 18MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12634422
• Report Number: 1526439-2021-02171
• Device Sequence Number: 4344825
• Product Code: KWQ
• UDI-Device Identifier: 10705034134123
• UDI-Public: (01)10705034134123
• Combination Product (Y/N): N
• PMA/510(K) Number: K171439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 186850018
• Device Catalogue Number: 186850018
• Device Lot Number: ATPB2C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1