MAUDE Adverse Event Report: STERILMED, INC.; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	STR4135-089-064
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Reciprocating saw blade broke intra-op during a total knee revision procedure.

• Brand Name: NA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire pkwy n ste 2; plymouth MN 55446
• MDR Report Key: 9436980
• Report Number: 9436980
• Device Sequence Number: 19442040
• Product Code: GFA
• UDI-Device Identifier: 10888551030755
• UDI-Public: (01)10888551030755
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2019
• Report Date (Section F): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: STR4135-089-064
• Device Catalogue Number: 4135-089-064
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 81
• Date Report Sent to FDA: 11/18/2019