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

Catalog Number	275010140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7130792
• Report Number: 1526439-2017-50101
• Device Sequence Number: 19302801
• Product Code: HXB
• UDI-Device Identifier: 10705034198415
• UDI-Public: 10705034198415
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1