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

Model Number 286750041

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, while passing the viper prime 6x40 screw mounted in its respective screwdriver and with the stylet, it did not easily enter the patient's bone and the surgeon decided to remove.It was evident that the stylet was bent and jammed in the screw.Procedure was completed successfully with few minutes of surgical delay.Concomitant device reported: mis single inner setscw (part# 186715000, lot# 299238, quantity 4).Mis cann poly scw 6x40mm,ti (part# 186715640 , lot# 149511, quantity 3).Mis cann poly scw 6x40mm,ti (part# 186715640, lot# tbvmf, quantity 1).Viper2 lordotic rod-45mm (part# 186788045, lot# tbxzy, quantity 1).Conf intro ndle, dia, 11g 6" (part# 283903611, lot# 271833, quantity 2).Viper prime stylet (part# 286750200s, lot# 585424431, quantity 1).Viper prime stylet (part# 286750200s, lot# si5326111 , quantity 1).This report is for one (1) prime stylet depth adjustor.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

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, the section/field of the form is left blank.H6 - codes updated to imdrf codes.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the image attached to the notes & attachments section of pc titled "image 1".The image was reviewed, and the complaint condition is not confirmed.There are no visible signs of damage or defects on the assembled devices that would contribute to the complaint condition.As the physical devices were not received, it cannot be confirmed that the devices cannot be disassembled.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) 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.Device history lot - a review of the receiving inspection (ri) for prime stylet depth adjuster was conducted identifying that lot number mf4328103 was released in a single batch.No discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review - the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

Manufacturer Narrative

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.H3, h6: a product investigation was completed: visual analysis of the returned sample revealed there are not significant product defects on the surface of the prime stylet depth adjustor.The device was returned in a disassembled condition.A dimensional inspection was performed for the prime stylet depth adjustor and met specifications.A functional test was not performed as the device was returned in a disassembled condition and the mating device was not returned.The current and manufactured to drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the prime stylet depth adjustor would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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: PRIME STYLET DEPTH ADJUSTOR
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12868480
• MDR Text Key: 281208200
• Report Number: 1526439-2021-02470
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034507644
• UDI-Public: (01)10705034507644
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K170937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 286750041
• Device Catalogue Number: 286750041
• Device Lot Number: MF4328103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/24/2021
• Supplement Dates Manufacturer Received: 12/22/2021; 03/31/2022
• Supplement Dates FDA Received: 12/22/2021; 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONF INTRO NDLE, DIA, 11G 6".; MIS CANN POLY SCW 6X40MM,TI.; MIS CANN POLY SCW 6X40MM,TI.; MIS SINGLE INNER SETSCW.; VIPER PRIME INSERTER CARRIER.; VIPER PRIME INSERTER SHAFT.; VIPER PRIME STYLET.; VIPER PRIME STYLET.; VIPER PRIME X-TAB, 6X40MM TI.; VIPER2 LORDOTIC ROD-45MM.
• Patient Sex: Male