MAUDE Adverse Event Report: DEPUY SPINE INC VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186715640

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The dhr of product code: 186715640.Lot : 293517 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 28.10.2020, qty: 300.Visual inspection: the mis cann poly scw 6x40mm,ti (p/n: 186715640, lot number: 293517) was received at us customer quality (cq).Visual inspection of the complaint device showed the threads of the polyaxial screw head was broken and the broken fragment was returned with the device.Also, there is several scratches were observed on the screw threads.Some cement was stuck to the screw threads.No other issues were observed with the returned device.Functional test: a functional assessment was performed on the complaint device, the device was not jammed or seized.The screw was able to move freely inside the polyaxial screw head.The reported condition for the jammed could not be confirmed.Can the complaint be replicated with the returned device(s)? no.Dimensional inspection: a dimensional inspection for the received device was not performed due to post-manufacturing damage.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint is confirmed as the device was received broken.However, reported condition for the jammed/seized could not be confirmed.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that part of the screw froze in the screw nest.There were no consequences for the patient reported.This report is for one (1) viper system cannulated polyaxial screw 5.5 x 6 x 40mm.This is report 1 of 1 for (b)(4).

• Brand Name: VIPER SYSTEM CANNULATED POLYAXIAL SCREW 5.5 X 6 X 40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12554946
• MDR Text Key: 274050102
• Report Number: 1526439-2021-02088
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034122342
• UDI-Public: 10705034122342
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 186715640
• Device Catalogue Number: 186715640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1