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

Model Number	N103A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2023
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.
Event or Problem Description
It was reported that during the procedure, it was noticed the needle broke off into the patient and the tip could not be located due to size.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences reported.
Additional Manufacturer Narrative
Update: the reported event could be not confirmed, because of the device has not been returned.H3 other text: discarded.
Event or Problem Description
It was reported that during the procedure, it was noticed the needle broke off into the patient and the tip could not be located due to size.The procedure was completed successfully.There was no clinically significant delay, no medical intervention, and no adverse consequences reported.

• Brand Name: COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 16610244
• Report Number: 0008010177-2023-00015
• Device Sequence Number: 14685375
• Product Code: ICO
• UDI-Device Identifier: 04546540004093
• UDI-Public: 04546540004093
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023
• 2 Devices were Involved in the Event: 1 2

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: 22203047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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
• Patient Sex: Unknown