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

Model Number	N103A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using the device during the procedure, the electrode burned the nasal mucosa of he patient, causing a small wound.The patient was checked for injury and disinfected and a new electrode was used to complete the surgery.
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.
Additional Manufacturer Narrative
The reported event could be not confirmed, because of the device has not been returned and no further information could be provided; although, additional information has been requested regarding the reported event.Corrected data: original catalog number reported on initial emdr was n103a and later discovered to be catalog n104a.Related to the lot code the relevant inspection and quality documents have been reviewed.The review showed that the product was manufactured in accordance with the specification and accepted into final stock with no reported discrepancies regarding the reported event.If additional information is received it will be reported on a supplemental report.
Event or Problem Description
It was reported that while using the device during the procedure, the electrode burned the nasal mucosa of he patient, causing a small wound.The patient was checked for injury and disinfected and a new electrode was used to complete the surgery.

• Brand Name: COLORADO NEEDLE, 4 CM STRAIGHT (3/32") SLEEVE
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: rylee koole ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 15620719
• Report Number: 0008010177-2022-00034
• Device Sequence Number: 6225277
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: N103A
• Device Catalogue Number: N104A
• Device Lot Number: 20335037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 10/09/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown