MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186731645

Device Problem Torn Material (3024)

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

Event Date 09/20/2016

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 surgeon tried to insert of a set screw into the screw head during surgery but unable to insert well.He replaced the other new set screw but this attempt was not successful.When he checked inside of screw head, the thread was broken.There was no adverse consequence to the patient and no further information was provided by hospital.

Manufacturer Narrative

(b)(4).The viper 5.5 ti 6x45mm cortical fix screw (product code: 1867-31-645, lot number: avfgdp) was returned to the complaints handling unit on october 13th, 2016.One side of the polyaxial screw¿s tulip head features a burred/cut notch at the top of one of the threads at the top of the screw.The opposite side of the tulip head features a thread that has been compressed downward and is partially broken away from the side of the tulip head.No other damage was found to the screw.The damage to the threads may have occurred during insertion of the set screw.If the set screw were cross-threaded upon insertion, additional stresses would be put on the threads of both the set screw and the polyaxial screw threads.This can potentially damage the threads of either device.Dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause for the polyaxial screw¿s threads becoming damaged cannot be determined from the sample and information provided.This damage may have occurred due to cross-threading a set screw upon insertion.Tightening the set screw while it is cross threaded places an unexpectedly high amount of force on the threads both the set screw and the polyaxial screw threads.This can potentially result in damage and/or tearing to the threads of both the set screw and polyaxial 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 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: SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 6X45MM
• 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: 6030050
• MDR Text Key: 57488671
• Report Number: 1526439-2016-10769
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110216
• 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: 09/20/2016

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: 186731645
• Device Lot Number: AVFGDP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 10/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2016
• 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