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

Catalog Number	550025S307
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation if the device is available.
Event or Problem Description
It was reported that during testing at the user facility, the tip broke.This event did not occur during a surgical procedure; no patient involvement or adverse consequences were reported.
Event or Problem Description
It was reported that during testing at the user facility, the tip broke.This event did not occur during a surgical procedure; no patient involvement or adverse consequences were reported.
Additional Manufacturer Narrative
Additional information: d4; catalog number, gtin, product long description and lot number provided.
Event or Problem Description
It was reported that during testing at the user facility, the tip broke.This event occurred prior to a surgical procedure; no patient involvement or adverse consequences were reported.It was reported that there was a small delay to the procedure.
Additional Manufacturer Narrative
Additional information: h6; the quality investigation is complete.Correction: d4; full udi provided.B5; a small delay to the procedure was reported.

• Brand Name: 12CM IQ STANDARD
• 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: 19313090
• Report Number: 3015967359-2024-01031
• Device Sequence Number: 3077270
• Product Code: LFL
• UDI-Device Identifier: 07613327422467
• UDI-Public: (01)07613327422467(17)251101(10)23314057
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Catalogue Number: 550025S307
• Device Lot Number: 23314057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/14/2024; 09/24/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/13/2024; 10/22/2024
• 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: 5500255000, S/N: (B)(6).
• Patient Sex: Unknown