MAUDE Adverse Event Report: DEPUY SYNTHES SPINE PEDICLE PROBE, CURVED

Catalog Number 279702020

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2016

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

Probe broke in pedicle.Complaint form sent.

Manufacturer Narrative

One (1) expedium pedicle probe ¿ curved [product code: 2797-02-020] was returned to the complaints handling unit (chu) for evaluation.Visual examination at the macroscopic level revealed that the fracture was located at the probe¿s distal tip.The fractured tip was not returned for evaluation.The fracture analysis report shows a rough grainy appearance across most of the surface with a smooth region to the left marking the likely initiation site and an irregular region to the right marking the likely termination site.These characteristics suggest the probe underwent a quasi-static overload failure.In addition to fracture analysis, a hardness test was performed on the part.The results from the hardness test showed that the average was within the specified hardness range.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.No emerging trends were found requiring further actions.A definitive root cause for the probe¿s distal tip breaking cannot be positively determined.However, the fracture analysis report shows a rough grainy appearance across most of the surface with a smooth region to the left marking the likely initiation site and an irregular region to the right marking the likely termination site.These characteristics suggest the probe underwent a 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 requiring immediate action have been observed, 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: PEDICLE PROBE, CURVED
• 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: 6028388
• MDR Text Key: 57399671
• Report Number: 1526439-2016-10756
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 279702020
• Device Lot Number: 0710NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1