MAUDE Adverse Event Report: STRYKER INSTRUMENTS-IRELAND COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE; INSTRUMENT

Model Number	N103A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Device discarded.
Event or Problem Description
It was reported that during the resection of the left parotid gland tumor, the skin was cut with a micro anatomical tungsten needle combined with an ultrasonic knife to cut and remove the tumor.It was noticed after the incision was closed that the tip of the needle was found to be 0.5mm short.

• Brand Name: COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• MDR Report Key: 12263097
• Report Number: 0008010177-2021-00039
• Device Sequence Number: 4454873
• Product Code: GEI
• UDI-Device Identifier: 04546540004093
• UDI-Public: 04546540004093
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

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: N103A
• Device Catalogue Number: N103A
• Device Lot Number: 18275177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1