MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO LONG ELITE IRRIGATION CLIP; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5100010272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure at the user facility an irrigating attachment was dropped on the floor.The item was picked up and placed on a tray of identical equipment and the case proceeded after a nurse verified the integrity of the equipment.The procedure was completed successfully.A few hours after surgery the central sterile department noted a broken tip on one of the irrigating attachments present during the case.The doctors for the case informed the patient of the broken tip.Follow-up x-rays on the patient did not detect any device fragments in the patient.No adverse consequences.
Event or Problem Description
It was reported that during a procedure at the user facility an irrigating attachment was dropped on the floor.The item was picked up and placed on a tray of identical equipment and the case proceeded after a nurse verified the integrity of the equipment.The procedure was completed successfully.A few hours after surgery the central sterile department noted a broken tip on one of the irrigating attachments present during the case.The doctors for the case informed the patient of the broken tip.Follow-up x-rays on the patient did not detect any device fragments in the patient.No adverse consequences.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: LONG ELITE IRRIGATION CLIP
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8877071
• Report Number: 0001811755-2019-02673
• Device Sequence Number: 2742809
• Product Code: ERL
• UDI-Device Identifier: 04546540352781
• UDI-Public: 04546540352781
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: 5100010272
• Device Catalogue Number: 5100010272
• Device Lot Number: TBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1