MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE SCREW, CORTICAL FIX, POLYAXIAL, MIS 5.5, TI, 8X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 186731850

Device Problems Material Separation (1562); Torn Material (3024)

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

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.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.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 was used in surgery for fracture (fractured location unknown), stabilizing th11-l5, on (b)(6) 2017.By applying pps (percutaneous pedicle screw) system, the surgeon tried to fix a rod.However, he had difficulty connecting the rod and the reported screw ¿5.5 cannulated cortical fix screw 8 x 50 mm (186731850).¿ after several connecting trials, an extender (part number unknown) came off.Although the surgeon tried to re-fix the extender in the patient¿s body, he could not complete the fixations of the extender as well as the rod connection.Next, the surgeon tried to remove the reported screw.But he found that metal parts in the reported screwhead had been accidentally disassembled.He used a replacing screw and completed the surgery with a 60-minute delay.There was no adverse consequence to the patient.

Manufacturer Narrative

Visual examination of the returned device found that the tulip head had become dislodged from its intended location and was now in the intended location of a rod and set screw.The tulip head itself was also damaged with torn threads.Screw head was also damaged.Drive feature is covered in tool marks.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.A trend analysis was conducted.No emerging trends were found requiring further actions.The root cause of the saddle being pushed into the tulip head and rotated cannot be determined from the sample and the information provided.A potential root cause may be unanticipated force placed on the screw during tightening.The stripping of threads may be if the driver tip is not fully flush with the screw head¿s drive feature during tightening.A potential root cause for the torn threads may be cross threading the set screw upon insertion into the tulip head.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 were found, 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, 8X50MM
• 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: 6656598
• MDR Text Key: 78047373
• Report Number: 1526439-2017-10479
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 186731850
• Device Lot Number: AVLBCD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR