MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PROBE

Catalog Number 25000300

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

Device fragment in patient.Radiological images review result:.Intra-op images of ilium instrumention were provided.Ap angle images show metallic fragment is present across the sacroiliac joint line.Without corresponding lateral view, it is difficult to know if this has returned in pelvis as it is at different trajectory than the instrumentation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that intra-op, tip of the probe broke off and remained in the si joint of the patient.No patient complications have been reported as a result of this event yet.

Manufacturer Narrative

X-ray review results: intra-op images for ilium instrumentation were provided.Ap angle shows a metallic fragment present across the sacroiliac joint line.Without corresponding lateral views, it is difficult to know if this is placed in the pelvis as it is at a different trajectory than the instrumentation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: visual observation reveals that the tip of the probe has been broken/sheared off and is missing from what appears to be overload.Hardness reveals that the probes are the proper hardness.This is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROBE
• Type of Device: PROBE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 9270315
• MDR Text Key: 164831564
• Report Number: 1030489-2019-01259
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25000300
• Device Lot Number: CT16A015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 61