MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, ST; PROBE

Catalog Number 279702030

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The expedium straight thoracic pedicle probe was returned to the customer quality unit (cqu).The probe was fractured approximately 40mm from the distal tip.The fractured tip was not returned for evaluation.An optical image of the fractured surface the probe 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.A supplemental hardness test was performed on the driver.This probe is within of the specified guidelines.No issues were identified during the manufacturing and release of this instrument that could contribute to the problem reported by the customer.This instrument was released accomplishing all quality requirements.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.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 due to unexpectedly high forces placed on the tip during use.No issues could be identified in the manufacturing or release of this product.Therefore, this complaint 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.

Event Description

Surgeon stated while using pedicle probe that he felt the tip was about to snap.The instrument was removed from the set and a like instrument was used to complete the surgery.Patient consequence? : no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Product complaint # (b)(4).Corrected data: device receipt date.

• Brand Name: XPDM THORACIC PEDICLE PRB, ST
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7266520
• MDR Text Key: 100250042
• Report Number: 1526439-2018-50137
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034198439
• UDI-Public: 10705034198439
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

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: Health Professional
• Device Catalogue Number: 279702030
• Device Lot Number: NW137215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• 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