MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 12CM IQ APEX 360; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B312
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Nerve Damage (1979)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported postoperative, the patient experienced right l5 area sensory loss, weakness of foot to toe muscles (foot medial rotation, drop toe), due to damage caused during use of the sonopet iq tip.It was further reported that the patient is doing well, and sensory loss has returned.It was also reported that the original procedure forl4-5 laminectomy, right herniotomy, was completed successfully, with no medical intervention or delays.
Additional Manufacturer Narrative
D4: full udi is not available due to missing lot number.H6: the quality investigation is complete.
Event or Problem Description
It was reported postoperative, the patient experienced sensory loss in left l3 area, thigh muscle weakness, due to damage caused during use of the sonopet iq tip.It was further reported that the patient is doing well, and sensory loss has subsided.It was also reported that the original procedure for right l5 area sensory loss, weakness of foot to toe muscles (foot medial rotation, drop toe), was completed successfully, with no medical intervention or delays.

• Brand Name: 12CM IQ APEX 360
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 19950804
• Report Number: 3015967359-2024-01679
• Device Sequence Number: 18373679
• Product Code: LFL
• UDI-Device Identifier: 37613327422413
• UDI-Public: (01)37613327422413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550025B312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5500050000 SONOPET IQ ULTRASONIC ASPIRATOR CONSOLE; 5500255000SONOPET IQ UNIVERSAL ANGLED HANDPIECE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown