MAUDE Adverse Event Report: DEPUY SYNTHES SPINE THORACIC PEDICLE PROBE, STRAIGHT

Catalog Number 279702030

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed 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

The instrument is fractured.

Manufacturer Narrative

(b)(4).Complaint sample was returned.A follow up report will be filed 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.

Manufacturer Narrative

Visual examination of the returned device found the probe was fractured at the distal tip.The fractured tip was not returned.Device was subsequently sent for fracture analysis.An optical image of the fractured surface reveals a rough grainy appearance consistent across the entirety of the surface with no evidence of fatigue striations.This suggests the probe underwent a quasi-static overload failure.No material defects or other abnormalities were observed in this analysis.Hardness testing was also performed.Device was within specified guidelines.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 probe tip breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is quasi-static 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: THORACIC PEDICLE PROBE, STRAIGHT
• Type of Device: PROBE
• 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: 6559740
• MDR Text Key: 74916057
• Report Number: 1526439-2017-10348
• Device Sequence Number: 1
• Product Code: HXB
• 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,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 279702030
• Device Lot Number: 0109NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2009
• 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