MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND N/A; BIT, SURGICAL

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Synthes 2.5 mm drill bit broke into two pieces, one remaining contained in the right ankle surgical site.Read free of any other metal fragments.Operating room team aware of events.

• Brand Name: N/A
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region court; lakeland FL 33815
• MDR Report Key: 7605243
• Report Number: 7605243
• Device Sequence Number: 18902947
• Product Code: GFG
• UDI-Device Identifier: 00885825011888
• UDI-Public: (01)00885825011888
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 310.23
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018