MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 TI CORT FIX 6X40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186731640

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

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

Surgeon facing difficulties using the viper 3d system persuader to persuade down the rod down which consists of few parts as below: 286735730 - derotation reduction threaded post, 286735725 - derotation reduction shaft, 286735750 - reduction cap, 286735735 - derotation reduction handle when surgeon tried to insert and tighten the innie nut, he wasn't able to turn the derotation reduction handle as it was tight.Then he took out the nut and found it has cross-threaded as well as the screw head.

Manufacturer Narrative

The 5.5 ti cortical fix 6x40mm screw was returned for evaluation.Visual inspection noted torn tulip head threads containing impaction marks.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively identified however the noted damage may have resulted from cross threading during set screw placement.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 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: 5.5 TI CORT FIX 6X40MM
• 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: 6714280
• MDR Text Key: 80062882
• Report Number: 1526439-2017-10581
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034351827
• UDI-Public: (01)10705034351827
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

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 Model Number: 186731640
• Device Catalogue Number: 186731640
• Device Lot Number: AVJCLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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