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 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Udi: (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

The material partially released its thread.The material was replaced.

Manufacturer Narrative

(b)(4).The single inner set screw (product code: 1797-02-000, lot number: atlbr4) was not returned to the customer quality unit (cqu).While it was initially identified that the set screw was available, three requests for its return were made without the sample or a tracking number being returned.As 37 days have passed without either being received, the status of the sample has been updated to ¿none.¿ the dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem identified by the customer.No emerging trends were found requiring further actions.Without the set screw, we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of this 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 actions required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4).The complaint was reopened after the sample was received on march 16th, 2017.The returned set screw (product code: 1797-02-000, lot number: atlbr4) featured a strand of its thread jutting out from the side of its body.This section of the thread notably starts out near the base of the set screw and covers approximately one full rotation around the body of the set screw.This damage is consistent with cross threading the set screw upon insertion.Attempting to tighten the set screw while in this configuration can damage the threads due to the stresses placed on them.The dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem identified by the customer.No emerging trends were found requiring further actions.The root cause for the thread of the set screw being torn from its body cannot be determined from the sample and information provided.This damage may have occurred due to inadvertently cross threading the set screw upon insertion.Tightening a screw while it is cross threaded places a high amount of force on the thread, potentially resulting in the thread being torn from the body of the set screw.As there has been no issue identified in the manufacturing or release of this 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 actions 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6354587
• MDR Text Key: 68291464
• Report Number: 1526439-2017-10139
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2017

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: No Information
• Device Catalogue Number: 179702000
• Device Lot Number: ATLBR4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/08/2017; 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1