MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MIS CANNULATED CORTICAL FIX X-TAB 5X35MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186750135

Device Problem Torn Material (3024)

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

Event Date 04/06/2017

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

The reported product ¿cortical fix x-tab 5x35mm ti ((b)(4))¿ was used in surgery for spinal canal stenosis, covering l2-l3, on (b)(6) 2017.Before inserting the reported screw, the surgeon cut tabs.Next, he tried to connect the screw with qc screw driver (part number unknown).Because there were some burrs left on the tabs, he could not, he could not connect them.He used a replacement (the same specifications), cut tabs prior to insertion, and completed the surgery with a 5-minute delay.There was no adverse consequence to the patient.

Manufacturer Narrative

(b)(4).One (1) cortical fix x-tab 5x35mm ti was returned for evaluation.Visual examination of the cortical fix x-tab 5x35mm ti revealed that it has a burr at its base with a torn thread.Burr consists of approximately 1/4th turn of thread material, which is attached to the 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.A definitive root cause cannot be determined from the returned cortical fix x-tab 5x35mm ti (product code: 1867-50-135) and information provided.A potential root cause may be unanticipated insertion methods, leading to the set screw cross-threading and damaging thread during insertion.Inadvertent interaction between the tabs of the cortical fix x-tab and the driver during aggressive insertion may have led to the tab breakage.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: MIS CANNULATED CORTICAL FIX X-TAB 5X35MM TI
• 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: 6543843
• MDR Text Key: 74427714
• Report Number: 1526439-2017-10320
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2017

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: 186750135
• Device Lot Number: TBMUB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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