MAUDE Adverse Event Report: DEPUY SPINE INC SKY CAM TIGHTENER SHAFT; DRIVER, PROSTHESIS

Model Number	286840000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
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.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.A review of the receiving inspection (ri) for sky cam tightener shaft , was conducted identifying that lot number nw260073 was released in two batch.Batch1: lot qty units were released on 30 july 2020 with no discrepancies.Supplier : (b)(4).¿ batch2: lot qty units were released on 30 july 2020 with no discrepancies.Supplier : (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that sky cam tightener shaft was stripped and worn.The observed condition was consistent as an end of life indicator for the device.The burr condition cannot be confirmed as there is no evidence in the photo of excess of material in the tip.Functionality of the device cannot be assessed through photo investigation.No other issues were identified.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for sky cam tightener shaft.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.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 australia as follows: it was reported on (b)(6) 2023, that the dr.Was doing a c2-4 acdf using a loan skyline kit.He implanted a 42mm plate (ref: 186.02.042) from the loan set and after doing an intraop x-ray he decided he needed to remove the plate and adjust it.When unlocking the cam locks the driver (2868-04-000) burred 1 of the cam locks and it made it impossible to disengage the lock.The screw was not able to be removed from the plate.The screw had to be reversed while still inside the plate.The same size plate from another set was used to complete the surgery.The surgery was delayed for 10 minutes.When event occurred 2 set of implants was opened and used.The procedure was successfully completed.No fragments were generated.No patient outcome/ consequences.This report is for one (1) sky cam tightener shaft.This is report 1 of 2 for 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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 tip of the sky cam tightener shaft was stripped and worn.The observed condition was consistent as an end of life indicator for the device.The stripped condition of the tip can be contributed to the unable to assemble condition of the screw stuck on the plate.No evidence of burr or a small amount of excess material attached were observed.The stripped condition of the device was consistent with a random component failure that may have been caused by exposure to excessive/unintended forces.A functional test could not be performed as the returned mating device has damage.A dimensional inspection was not performed as it is not applicable to the complaint condition.The device exhibits damage consistent with repeated use.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the sky cam tightener shaft would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SKY CAM TIGHTENER SHAFT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16552427
• Report Number: 1526439-2023-00498
• Device Sequence Number: 2970036
• Product Code: HWR
• UDI-Device Identifier: 10705034215457
• UDI-Public: (01)10705034215457
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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

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
• Device Model Number: 286840000
• Device Catalogue Number: 286840000
• Device Lot Number: NW260073
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SKYLINE ANTERIOR CERVICAL TWO LEVEL PLATE 42MM.; UNKNOWN SCREWS.
• Patient Sex: Unknown