MAUDE Adverse Event Report: DEPUY SPINE INC MONOAXIAL SCREWDRIVER; SCREWDRIVERS

Model Number	279712830
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date during an unknown procedure, the monoaxial screwdriver did not retain the screw properly.There was no patient consequence.There was no surgical impact.The procedure was completed using an alternative instrument.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) monoaxial screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: MONOAXIAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11386139
• Report Number: 1526439-2021-00367
• Device Sequence Number: 11793509
• Product Code: HXX
• UDI-Device Identifier: 10705034199092
• UDI-Public: 10705034199092
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 279712830
• Device Catalogue Number: 279712830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS