MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186803066
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.A photo-investigation was performed upon inspecting the images provided, it was observed that the one of the top screws was deformed which could have caused the complaint condition.However, the root cause of the breakage cannot be determined based on the available image.A functional test was not able to perform since the device was not returned but the overall complaint condition can be confirmed from the provided images.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.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Conclusion: the complaint condition can be confirmed during photo 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 history lot: the combination of the product code: 186803066 and lot number: 303136 doesn't exist in our system, please let us know if any update is done on it.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 on an unknown date that the skyline screwdriver cam tightener shaft broke during a demonstration to the surgeon.There was no procedure and patient involved.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This complaint involves (2) devices.This report is for (1) skyline anterior cervical plate system three level plate 66mm.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: investigation summary: investigation flow: damage/ device functional.Visual inspection: the sky 3 level plte 66mm ti (p/n: 186803066, lot #:303136) was returned and received at us cq.Upon visual inspection, it was observed that one of the blocking screw was found little deformed.No other defects were observed with the plate.Functional test: the functional test cannot be performed as the mating device is damage.The alleged complaint condition could have happened due to the deformation of one of the blocking screw on plate.The complaint can not be replicated with the returned device.Device failure/defect is identified.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, all related drawings are reflecting the current and manufactured revision were reviewed: complaint was confirmed.The deform condition of the blocking screw on the plate could have complaint condition of "jammed/seized" when trying to remove through the sky cam tightener shaft.Investigation conclusion: the complaint condition is confirmed for the sky 3 level plte 66mm ti (p/n: 186803066, lot #:303136).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot: the combination of the product code: 186803066 and lot number: 303136.Doesn't exist in our system.Manufactured date: 15-mar-2021.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(6) no manufacturing record evaluation is required.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: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM THREE LEVEL PLATE 66MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12681591
• Report Number: 1526439-2021-02233
• Device Sequence Number: 4298009
• Product Code: KWQ
• UDI-Device Identifier: 10705034133850
• UDI-Public: (01)10705034133850
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 186803066
• Device Catalogue Number: 186803066
• Device Lot Number: 303136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown