MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.0MM SWANSON PILOT POINT BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	1608002131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a proximal interphalangeal (pip) joint surgical procedure, the tip of the bur broke.It was also reported that the broken tip was embedded in the bone, attempts were made to remove the tip, but it could not be found.It was further reported that there were no delays as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Device evaluated by mfr: investigation results indicate that the bur potentially had contact with metal (cut guides or surgical instruments)the potentially resulted in overload conditions causing the rounded tip to fracture away from the rest of the bur.The ifu(instructions for use) of attachments associated with this device warn the user against this type of use: "do not apply excessive pressure.Monitor heavy side loads and/or long operating periods to prevent overheating of the distal tip and body of the handpiece and/or attachment.Excessive pressure may bend or fracture the cutting accessory" the quality investigation is complete.
Event or Problem Description
It was reported that during a proximal interphalangeal (pip) joint surgical procedure, the tip of the bur broke.It was also reported that the broken tip was embedded in the bone, attempts were made to remove the tip, but it could not be found.It was further reported that there were no delays as a result of this event and the procedure was completed successfully.

• Brand Name: 2.0MM SWANSON PILOT POINT BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8898338
• Report Number: 0001811755-2019-02704
• Device Sequence Number: 286010
• Product Code: GFF
• UDI-Device Identifier: 04546540030528
• UDI-Public: 04546540030528
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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 Expiration Date: 01/01/2024
• Device Catalogue Number: 1608002131
• Device Lot Number: 19003017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention