MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 186100001

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

Device is available for investigation.Investigation will be conducted.Follow up will be filed with the findings.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 distracted the growing rod construct and during final tightening, the single innie setscrew stripped out.

Manufacturer Narrative

Visual examination of the returned device revealed the threads were peeled and torn.A review of the device history record could not be performed as the lot number was illegible.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause cannot be positively determined.However, based on the visual evaluation of the returned sample, the possible cause of the defect is the instrument been subjected to excessive force or anticipated torsional forces during use.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: EXPEDIUM
• 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): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 7008963
• MDR Text Key: 92480195
• Report Number: 1526439-2017-10942
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034103846
• UDI-Public: (01)10705034103846
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• 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: 10/11/2017

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: 186100001
• Device Catalogue Number: 186100001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1