MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC ORTHOPEDIC MANUAL SURGICAL INSTRUMENT; PROBE

Catalog Number EX0712190

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 04/25/2017

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Pre-operative diagnosis for this procedure: scoliosis levels implanted: t2-l1 it was reported that during surgery, the probe was being used to feel the track made by the thoracic probe to place the screw.The ball on the end broke off and remained inside the patient.No patient complications were reported.

Manufacturer Narrative

Correction: product analysis: visual examination confirms probe bent in multiple locations, with probe tip breakage approx.~8mm from the probe tip end.The broken off portion of the tip is missing and not returned for analysis.Optical examination reveals a fairly tortuous fracture surface, consistent with bend stress overload.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 6577579
• MDR Text Key: 75515324
• Report Number: 1030489-2017-01248
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: EX0712190
• Device Lot Number: TU12J001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 08/03/2017; 08/03/2017
• Supplement Dates FDA Received: 08/17/2017; 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2012
• 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
• Patient Outcome(s): Other