MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG COLORADO NEEDLE, 4 CM STRAIGHT (3/32") SLEEVE; INSTRUMENT

Model Number	N104A
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	06/04/2020
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 at facility.
Event or Problem Description
It was reported that the tip of the electrode broke when using the colorado needle intra-operatively.The procedure was completed using a backup colorado needle, and no adverse consequences were reported.
Additional Manufacturer Narrative
Since the original mdr #2427185 was filed new information was found and assessed internally.The review shows that there were no previous adverse consequences nor patient harm as a result of this specific product failure (associated with this risk line item).Therefore, it has been determined the complaint is not a reportable as this product malfunction has not led to an adverse event in the past, nor is it likely that it would lead to an adverse event if it were to happen again.Device discarded at facility.
Event or Problem Description
It was reported that the tip of the electrode broke when using the colorado needle intra-operatively.The procedure was completed using a backup colorado needle, and no adverse consequences were reported.

• Brand Name: COLORADO NEEDLE, 4 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10219444
• Report Number: 0008010177-2020-00035
• Device Sequence Number: 573392
• Product Code: GEI
• UDI-Device Identifier: 04546540004116
• UDI-Public: 04546540004116
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 02/15/2021

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: N104A
• Device Catalogue Number: N104A
• Device Lot Number: 19347037
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1