MAUDE Adverse Event Report: DEPUY SPINE INC SKYLINE EXPANSION TIP DRIVER; 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	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025 while placing screws and the self retaining expansion screwdriver was not holding the screw.Expansion screwdriver was removed from case.There was no patient status/ outcome / consequences and surgical delay.
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.Additional narrative: investigation summary photographs were provided but they do not represent the current complaint condition or a device malfunction according to the information received, ¿it was reported that on mar 6, 2025 while placing screws and the self retaining expansion screw driver was not holding the screw.Expansion screw driver was removed from case.There was no patient status/ outcome / consequences and surgical delay" the product was not returned to medtech orthopaedics, however photos were provided for review.The photographs attached were reviewed, however the provided evidence was not sufficient to confirm the reported event of unable to assemble.Functionality issues cannot be evaluated through a photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, 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 complaint condition.As part of medtech orthopaedics 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 history a review of the receiving inspection (ri) for skyline expansion tip driver was conducted identifying that lot number gm5063504 was released in two batches.¿ batch1: lot qty of (b)(4) units were released on 09 oct 2018 with no discrepancies.¿ batch2: lot qty of(b)(4) units were released on 05 feb 2019 with no discrepancies.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.H11 additional narrative: added: d10 (concomitant).H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the tip of the skyline expansion tip driver is seen stripped, this condition can be a main factor to not assemble into the mating device as expected confirming the complaint allegation.No other finding is seen.A dimensional inspection was not 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 j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the skyline expansion tip driver would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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 review (dhr): a review of the receiving inspection (ri) for skyline expansion tip driver was conducted identifying that lot number: gm5063504 was released in two batches.Batch 1: lot qty of (b)(4) units were released on 09 oct 2018 with no discrepancies.Batch 2: lot qty of (b)(4) units were released on 05 feb 2019 with no discrepancies.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SKYLINE EXPANSION TIP DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 21742253
• Report Number: 1526439-2025-00432
• Device Sequence Number: 8797945
• Product Code: HWR
• UDI-Device Identifier: 10705034215426
• UDI-Public: (01)10705034215426(10)GM5063504
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 286830500
• Device Lot Number: GM5063504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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: UNKNOWN SCREWS.
• Patient Sex: Unknown