MAUDE Adverse Event Report: DEPUY SPINE INC QUICK CONNECT SI POLYDRIVER; SCREWDRIVER

Model Number	698340694
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E1: state: british columbia.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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
Device report from depuy synthes reports an event in canada as follows: it was reported that while inserting some very long expedium polyaxial screws into the iliac crest/sacral area during spine surgery, (9x80mm & 10x100mm) the tips of two screwdrivers stripped and broke due to the sheer force required to insert them into the bone.The surgeon was still able to advance the screw using a small rod inserted into the head of the implant and secured with a set screw along with an anti-torque sleeve which helped rotate the screw forward by forcing the rod around.Surgery was delayed 10min due to the reported event.The procedure was completed successfully.This complaint involves two (2) devices.This report is for one (1) quick connect si polydriver.This is report 2 of 2 for complaint (b)(4).

• Brand Name: QUICK CONNECT SI POLYDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16868316
• Report Number: 1526439-2023-00795
• Device Sequence Number: 5420595
• Product Code: HXX
• UDI-Device Identifier: 10705034466743
• UDI-Public: (01)10705034466743
• 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: Physician
• 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 Model Number: 698340694
• Device Catalogue Number: 698340694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM.; XPDM QUICK-CON SI POLY SCWDRVR.; XPDM THORACIC PEDICLE PRB, CRV.; XPDM THORACIC PEDICLE PRB, CRV.
• Patient Sex: Unknown