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

Model Number	8670001
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1030489-2022-00406
• Device Sequence Number: 20160681
• Product Code: LXH
• UDI-Device Identifier: 00721902293115
• UDI-Public: 00721902293115
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/27/2022
• Date Device Manufactured: 01/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 57 KG