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

Catalog Number	279722400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
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.H11 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 the patients bone was particularly hard and the insertional torque was too high when inserting the pelvic screws and the tip of 2 screwdrivers snapped off in the screws during the procedure on (b)(6) 2024.The screws were removed and no fragments were left in the patient.An alternative screw and screwdriver was used to complete the procedure.There was no patient impact.This report is for one (1) xpdm quick-con di poly scwdrvr this is report 2 of 4 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.H11 additional narrative: h3, h4 h6: a review of the receiving inspection (ri) for xpdm quick-con di poly scwdrvr, was conducted identifying that lot number 0110mi as released in batch.Batch1: lot qty of (b)(4) units are released on jan 13, 2010, 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.An analysis of the product could not be performed since a physical sample was not received for evaluation.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.H6 component code: g07002 (appropriate term/code not available) used to capture no findings available due to no product returned.Corrected data: d4: udi 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
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 19636220
• Report Number: 1526439-2024-01737
• Device Sequence Number: 17928695
• Product Code: HXX
• UDI-Device Identifier: 10705034199344
• UDI-Public: (01)10705034199344(11)100113(10)0110MI
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,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: 279722400
• Device Lot Number: 0110MI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2010
• 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; UNKNOWN SCREWS; XPDM QUICK-CON DI POLY SCWDRVR
• Patient Sex: Unknown