MAUDE Adverse Event Report: STRYKER CORPORATION; BUR, SURGICAL, GENERAL PLASTIC SURGERY

Model Number	1608002131
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Per operative note:.A starting awl was placed at the middle phalanx in the central aspect slightly dorsal.There was hard, thick and cortical bone.Therefore, a swanson bur was used.A high-speed bur to bur was used to create a starting point.The tip of the burr did break off down the medullary canal of the middle phalanx and was not retrievable.After creating a starting point, the awl was used in order to create room for our broach.We then sequentially broached up to a size 20 to match our proximal phalanx.The broach seated nicely, and it also fit tightly down the medullary canal of the middle phalanx cortex.This was checked under fluoroscopy while performing the broaching.The broach was central down the medullary canal, and it was a tight fit.It was felt that this was appropriate size for our arthroplasty.The area was then copiously irrigated, our outer gloves were changed, and all towel lint removed from the hand table.The area was once again irrigated.

• Brand Name: NA
• Common Device Name: BUR, SURGICAL, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10791974
• Report Number: 10791974
• Device Sequence Number: 19571637
• Product Code: GFF
• UDI-Device Identifier: 04546540030528
• UDI-Public: (01)04546540030528(17)250801(10)20213017
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2020
• Report Date (Section F): 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1608002131
• Device Catalogue Number: 1608002131
• Device Lot Number: 20213017
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2020
• 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: Other
• Patient Weight: 67
• Date Report Sent to FDA: 10/20/2020