MAUDE Adverse Event Report: DEPUY SPINE INC EXP ANT X25 TORQUE DRVR SHFT; DRIVER, PROSTHESIS

Model Number	287720170
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the receiving inspection (ri) for exp ant x25 torque drvr shft was conducted identifying that lot number so2040463 was released in a single batch.Batch 1: lot qty of (b)(4) units were released on 08 jul 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.Visual inspection: the exp ant x25 torque driver shft (p/n: 287720170, lot #: so2040463) was returned and received at us customer quality (cq).Upon visual inspection, the distal tip of the device was observed to be stripped and worn.Due to the worn condition of the tip, device functionality was compromised.The noted issues were consistent as end of life indicators for the device.The provided photographs were reviewed and no additional issues were observed.The received condition was consistent with the complaint condition thus the complaint was confirmed.Conclusion: after a visual inspection per guidance, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 during a left thoracolumbar approach for anterior fusion from t11-l3 the tip of the x25 shaft became distorted and would not lock off when locking off the set screw.The driver was replaced and all sets screws were locked off.The procedure was completed successfully with no consequences.Concomitant device reported: unknown set screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) torque driver shaft x25.This is report 1 of 1 for (b)(4).

• Brand Name: EXP ANT X25 TORQUE DRVR SHFT
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11556577
• Report Number: 1526439-2021-00518
• Device Sequence Number: 14472079
• Product Code: HWR
• UDI-Device Identifier: 10705034219523
• UDI-Public: 10705034219523
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: 287720170
• Device Catalogue Number: 287720170
• Device Lot Number: SO2040463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1