MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MIS TI CANNULATED X-TAB POLY SCREW, 7.0MM X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186770040

Device Problems Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be submitted 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 surgeon broke off the tab of the screw above the intended detachment point.As a result, a portion of the tab remained attached to the screw.

Manufacturer Narrative

The tab portion was returned for evaluation.Visual examination of the tab reveals that it was broken prematurely at the top of the tab.A review of the device history records could not be performed as the lot number was not provided.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause cannot positively be determined.However, a possible cause may be that the surgeon broke off the tab of the screw above the intended detachment point.No systemic trends requiring immediate action have been observed.Therefore, 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: MIS TI CANNULATED X-TAB POLY SCREW, 7.0MM X 40MM
• 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: 6629847
• MDR Text Key: 77410646
• Report Number: 1526439-2017-10421
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186770040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 53 YR