MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SUMMIT; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 174661031

Device Problem Break (1069)

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

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

Gtin: unknown.Device is available for evaluation.Investigation will be conducted.Follow up will be filed with findings if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Breakage.The device broke during using in the posterior cervical approach operation.There is no report on patient's injury.The sales name is (b)(4), as the system error, chose the wrong sales.

Manufacturer Narrative

Device was not returned for evaluation.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.Without the returned of the device we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned to manufacturer.

Manufacturer Narrative

The occipital plate was returned for evaluation.Visual inspection revealed that plate washer had fractured.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 cannot be positively identified however the observed damage suggests that the washer underwent an overload failure.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: SUMMIT
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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: 6954127
• MDR Text Key: 90053608
• Report Number: 1526439-2017-10846
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2017

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 Catalogue Number: 174661031
• Device Lot Number: WA2367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 10/26/2017; 11/07/2017
• Supplement Dates FDA Received: 11/06/2017; 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 70