MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SKY 1 LEVEL PLTE 18MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186801018S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Product code: 186801018s.Lot: 267274 manufacture date: january 6, 2020.Manufacturing location: (b)(4).Expiration date: june 13, 2047 a search was performed and no non-conformances were identified.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 sky 1 level plte 18mm ti was damaged.The plate presents a shape deformation and on the cam locks shape.The screws that cannot be disassembled from the plate are at angles that exceed the recommendation of the technique guide.The angle of the screw most likely caused excessive force to be required to unlock the cam resulting in the observed damage and inability to unlock the screws.The findings are consistent with reported "unable to disassemble" condition.No other issues were found.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for sky 1 level plte 18mm ti as the observed condition 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.*********************************************** drawing/specifications reviewed current and manufactured revisions were reviewed.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 during a procedure on (b)(6) 2021, the cam log mechanism couldn't be opened to remove the screws.The screws needed to be opened to re-position the plate.The surgeon ended up removing the plate with the screws.Procedure was completed successfully with a thirty minute delay.Patient status was good.Upon manufacturer receipt and investigation of the device, it was determined that the angle of the screws most likely caused excessive force to be required to unlock the cam resulting in the plate deformation and inability to unlock the screws.This report is for a sky 1 level plte 18mm ti.This is report 1 of 1 for (b)(4).

• Brand Name: SKY 1 LEVEL PLTE 18MM TI
• 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): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 13864598
• Report Number: 1526439-2022-00445
• Device Sequence Number: 4692487
• Product Code: KWQ
• UDI-Device Identifier: 10705034411866
• UDI-Public: (01)10705034411866
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 186801018S
• Device Catalogue Number: 186801018S
• Device Lot Number: 267274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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: UNKNOWN SCREWS
• Patient Age: 62 YR
• Patient Sex: Unknown