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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a distributor that in a medical procedure the tip of the device broke during skin incision.The fragment was not found in a post-op ct of the patient.No adverse consequences were reported with this event.The procedure was reported as completed successfully with a delay of less than 5 minutes, and that there are not any post-op symptoms for the patient.
Additional Manufacturer Narrative
Investigation conclusion: the investigation results show that the tip of the returned colorado needle is broken off.Therefore, the reported event could be confirmed.The fracture surface of the needle was damaged due to friction with its counterpart and the remaining surface shows the appearance of a fatigue fracture.The protruding part aside of the breakage surface indicates that the fracture was caused by bending overloads most likely due to collisions with hard objects.No lot number was provided and a review of the specific manufacturing batch record and related quality documents (manufacturing documents, inspection plan, inspection drawing and release report) cannot be performed.Therefore, it is also not possible to determine the quantity released for distribution within the affected lot.Further investigations and a review of additional documentation such as x-rays, medical assessments or patient records were not considered necessary, because of the conclusively determination of the main root cause (missing/broken off tip due to bending overloads) conclusively, no indication for an incorrectly working product or any systematic design, material or manufacturing related issue were found.
Event or Problem Description
It was reported by a distributor that in a medical procedure the tip of the device broke during skin incision.The fragment was not found in a post-op ct of the patient.No adverse consequences were reported with this event.The procedure was reported as completed successfully with a delay of less than 5 minutes, and that there are not any post-op symptoms for the patient.

• Brand Name: COLORADO NEEDLE, 3 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; carrigtwohill bus. & tech park; freiburg D-791 11; GM D-79111
• MDR Report Key: 10124656
• Report Number: 0008010177-2020-00025
• Device Sequence Number: 2342010
• Product Code: GEI
• UDI-Device Identifier: 04546540004093
• UDI-Public: 04546540004093
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K033232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N103A
• Device Catalogue Number: N103A
• Device Lot Number: WE COULDN'T GET LOT#
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1