MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MONARCH; WRENCH

Model Number 277040510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spinal Column Injury (2081)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On an unknown date, surgery for idiopathic scoliosis (type 5) was performed using the expedium system.The fixed area was t10 ¿ l3.A couple of months after the surgery, corrective force was significantly lost and the patient had a lower back pain.The surgeon judged that loss of the corrective force was due to loosening of the set screws.On (b)(6) 2017, re-operation was performed where it was confirmed that five (5) set screws were loosened and two (2) set screws were dislocated.The surgeon took the following procedures during the surgery.Corrected the fixed area again.Replaced the seven (7) set screws (part#: 179702000, lot#: unk) with new ones.Reinforced the area of a possible risk of loosening.The re-operation was successfully completed without any delay.The surgeon experienced this sort of event for the first time, so he would like to know about our opinion based on in-depth investigation.

Manufacturer Narrative

The torque wrench handle was returned for evaluation.Visual inspection found signs of superficial wear.Torque testing found the device to be out of specification.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 torque handle exerting less torque than intended cannot be determined from the sample and the information provided.A potential root cause may be wear and tear to the device over many uses.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: MONARCH
• Type of Device: WRENCH
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7080128
• MDR Text Key: 93633699
• Report Number: 1526439-2017-11029
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034196770
• UDI-Public: (01)10705034196770
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 277040510
• Device Catalogue Number: 277040510
• Device Lot Number: KM838614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR