MAUDE Adverse Event Report: DEPUY SPINE INC SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EXPANSION TIP SCREWDRIVER; DRIVER, PROSTHESIS

Catalog Number	286830500
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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.H11 additional narrative: e3: reporter is a j&j employee.H3, h4, h6: a review of the receiving inspection (ri) for skyline expansion tip driver, was conducted identifying that lot number gm5397216 was released in one batch.Batch1: lot qty of (b)(4) units were released on apr 6, 2020 with no discrepancies.Supplier : depuy : (b)(6).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 photographs attached were reviewed, however in the images provided no observations pertaining to the nature of the reported event could be identified such unable to unable to hold/ retain.The provided evidence was not sufficient to confirm the reported event.Functionality issues cannot be evaluated through a photo investigation.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the tip of the skyline expansion tip driver stripped.This condition can be one factor of the unable to hold into the mating device.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed due to post manufacturing damage.A functional evaluation was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the device would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to component failure, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 during a spinal fusion procedure on (b)(6) 2024, the nurses were having issues loading the screws with the caddy and the expansion tip screwdrivers (2).As well, the surgeon stripped and broke the cam tightener.He was able to retrieve the broken piece, which was subsequently discarded.The patient did not suffer from consequences and there was no delay.Procedure was completed successfully.This report is for a skyline anterior cervical plate system expansion tip screwdriver.This is report 2 of 3 for (b)(4).

• Brand Name: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM EXPANSION TIP SCREWDRIVER
• 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: 19655481
• Report Number: 1526439-2024-01761
• Device Sequence Number: 20454022
• Product Code: HWR
• UDI-Device Identifier: 10705034215426
• UDI-Public: 10705034215426
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 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 Catalogue Number: 286830500
• Device Lot Number: GM5397216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• 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: SKY CAM TIGHTENER SHAFT; SKY VARIABLE SCW CADDY; SKYLINE EXPANSION TIP DRIVER
• Patient Sex: Unknown