MAUDE Adverse Event Report: DEPUY SPINE INC PRIME STYLET DEPTH ADJUSTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	286750041
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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 spine reports an event in (b)(6) as follows: it was reported that on an unknown date in 2021 during the procedure, (1) unknown screwdriver, (1) viper prime handle, and (1) prime stylet depth adjustor were unable to be disassembled.There was no patient consequence.There was no surgical delay.The procedure was successfully completed by using another screwdriver in the set.This report is for (1) prime stylet depth adjustor.This is report 2 of 3 for (b)(4).

• Brand Name: PRIME STYLET DEPTH ADJUSTOR
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11489587
• Report Number: 1526439-2021-00447
• Device Sequence Number: 11886535
• Product Code: OLO
• UDI-Device Identifier: 10705034507644
• UDI-Public: (01)10705034507644
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170937
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2021

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: 286750041
• Device Catalogue Number: 286750041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1