MAUDE Adverse Event Report: DEPUY SPINE INC XPDM QUICK-CON SI POLY SCWDRVR; SCREWDRIVERS

Model Number 279712400

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is (b)(6) representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent for a surgery.Before the procedure, it was discovered that the end of the screwdriver is broken so it couldn't be used.Another one was used to complete the procedure.There was no fragment generated.There was no delay reported.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) xpdm quick-con si poly screwdriver.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: the investigation could not be completed and no conclusion could be drawn at the time of filing this report.The product is not available to return for investigation.The customer is retaining the device.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: XPDM QUICK-CON SI POLY SCWDRVR
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11098197
• MDR Text Key: 245708160
• Report Number: 1526439-2020-02516
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10705034198897
• UDI-Public: 10705034198897
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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 Model Number: 279712400
• Device Catalogue Number: 279712400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 02/26/2021
• Patient Sequence Number: 1