MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SINGLE INNER SET SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179702000

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

We got informed today about a revision surgery that took place (b)(6), because of implant failure.Primary surgery was about 3 years ago, multilevel fusion.Revision now had to be done because the rods broke at the 11/12.During the revision surgery, universal connectors were used for placing a third rod, parallel to the construct.At one of the connectors, the innie screw failed /the threads of the innie screw disconnected from the body.Implants were not picked up yet, but will be made available for examination.

Manufacturer Narrative

(b)(4).Two single inner set screws (product code: 1797-02-000, lot numbers: anfc9g, avhdg6) were returned to the customer quality unit (cqu).The set screw from lot avhdg6 is missing nearly all of its thread with the exception of the final quarter turn¿s worth of material.The remainder is missing entirely from the side of the set screw¿s body beyond markings on its surface.It is a possibility that some of the thread broke off into the space between threads of the top notch connector.The controlled manner of the damage is indicative of the set screw being tightened into the connector or an associated screw while cross threaded.Tightening the set screw while it is cross threaded can lead to stress building up on the thread, resulting in part of the thread splitting off from the body of the set screw.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the set screw¿s thread being torn cannot be determined from the sample and the information provided.A potential root cause may be cross threading the set screw upon insertion into the top notch connector.Tightening the set screw when it is cross threaded places force on the set screw¿s thread that can result in tearing the thread from the body of the set screw.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SINGLE INNER SET SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6471756
• MDR Text Key: 72271815
• Report Number: 1526439-2017-10236
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

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: Physician
• Device Catalogue Number: 179702000
• Device Lot Number: AVHDG6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1