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

Model Number 8670001

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having t12bkp, t10, 11, 12, l1 posterior fixation for osteoporotic vertebral compression fracture.It was reported that after the bkp procedure, when inserting a screw into the affected vertebra, a guidewire was inserted.After inserting the screw, the guidewire could not be removed. the screw was removed and the guidewire was cut. 20 mm tip of guidewire remains in the cement inside the vertebral body.There was a delay in procedure but less than 60 minutes.There were no patient symptoms or complications reported as a result of this event.Additional information received from manufacturer representative that the product is still in use and not returning for analysis.

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.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GUIDEWIRES
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14217224
• MDR Text Key: 290149993
• Report Number: 1030489-2022-00406
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00721902293115
• UDI-Public: 00721902293115
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8670001
• Device Catalogue Number: 8670001
• Device Lot Number: KH21G240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Date Device Manufactured: 01/05/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 57 KG