MAUDE Adverse Event Report: DEPUY SPINE INC XPDM QUICK-CON DI POLY SCWDRVR; SCREWDRIVER

Catalog Number 279722400

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported that some instruments were observed to not be in great condition while going through/restocking the sets.There was no patient involvement/consequences.This report is for one (1) xpdm quick-con di poly scwdrvr.This is report 3 of 5 for complaint (b)(4).

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.E3: reporter is a j&j sales representative.H3, h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.¿ visual investigation of the returned device found that the xpdm quick-con si poly scwdrvr has stripped from the tip.The stripped condition can be attributed to the correct functionality of the device.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.A dimensional inspection for the xpdm quick-con si poly scwdrvr was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the xpdm quick-con si poly scwdrvr would have contributed to the complained 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.Dw 2797_22_400 rev.J current and manufactured.Dimensional inspection: n/a h4, h6 a review of the receiving inspection (ri) for xpdm quick-con di poly scwdrvr was conducted identifying that lot number mi61049 released in one batch.Batch1: lot units were released on aug 24, 2017 with no discrepancies.Supplier: micropulse incorporated.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.

• Brand Name: XPDM QUICK-CON DI POLY SCWDRVR
• Type of Device: SCREWDRIVER
• 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: 17806994
• MDR Text Key: 324124010
• Report Number: 1526439-2023-01799
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034199344
• UDI-Public: (01)10705034199344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 279722400
• Device Lot Number: MI61049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CLIP-ON RED DEVICE DI IMPLANTS; CLIP-ON RED DEVICE DI IMPLANTS; CLIP-ON RED DEVICE DI IMPLANTS; CLIP-ON RED DEVICE DI IMPLANTS; FRENCH ROD BENDER; PEDICLE PROBE, STRAIGHT; ROD CLAMP, RATCHETING,STRAIGHT; SFX X20 TORQUE DRIVER SHAFT; SINGLE INNIE INSERTER; TORQUE WRENCH; X25 FINAL TIGHTENER