MAUDE Adverse Event Report: DEPUY SYNTHES SPINE BALL TIP FEELER STRAIGHT; PROBE

Catalog Number 275010140

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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

Feeler probe tip broke off in pedicle.Retrieved and surgery proceeded.Patient consequence? no.Action taken for procedure: retrieved broken piece.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

Manufacturer Narrative

(b)(4).Visual examination of the returned device noted the distal tip was fractured.An analysis was performed to investigate the fracture of a ball tip feeler, straight (product code: 275010140, lot no: ty15109).An optical image of the fractured surface shows plastic deformation and a rough appearance across the entire surface indicating the feeler tip underwent a static overload failure.The shaft of the feeler also exhibited plastic deformation with bending.No material defects or other abnormalities were observed in this analysis.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.A definitive root cause for the broken ball tip feeler, straight cannot be determined.However, fracture analysis suggests that fractured surface shows plastic deformation and a rough appearance across the entire surface indicating the feeler tip underwent a 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: BALL TIP FEELER 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 ; 5088808100
• MDR Report Key: 7130792
• MDR Text Key: 95897966
• Report Number: 1526439-2017-50101
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198415
• UDI-Public: 10705034198415
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 275010140
• Device Lot Number: TY15109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2011
• 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