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	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.A manufacturing record evaluation was could not be performed as the lot number could not be determined from the image(s).Customer quality investigation: the instrument(s) was not returned, and the investigation will be completed based on the supplied image(s).The image(s) was reviewed, and the complaint condition is unconfirmed as the picture did not show any signs of damage that would lead to functionality issues and no video showing any disassembling issues.As the instrument(s) was not returned and as received, dimensional, material or drawing reviews are not applicable.A manufacturing record evaluation was could not be performed as the lot number could not be determined from the image(s).There is no indication that a design or manufacturing issue contributed to the complaint as it was unconfirmed.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 that there was a problem with the screwdriver anchor and the rest of the screwdriver parts.The surgery was extremely complicated, and the stylet was bent several times so it had to be assembled and disassembled it repeatedly.The nut that secures the screws was locked at the moment of loosening the screw and the piece that moves the stylet forward began to make noises than it should not have made.The surgery was completed successfully.Without any affectation to the patient.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).Unknown depth adjustor (part# unknown, lot# unknown, quantity unknown).This report is for one (1) prime stylet depth adjustor.This is report 2 of 4 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: 11786302
• Report Number: 1526439-2021-00918
• Device Sequence Number: 17055479
• Product Code: OLO
• UDI-Device Identifier: 10705034507644
• UDI-Public: 10705034507644
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 04/09/2021

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: 04/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1