MAUDE Adverse Event Report: FH INDUSTRIE COLS; REAMER

Model Number	250102
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The reamer broke during the operation inside the knee.

• Brand Name: COLS
• Common Device Name: REAMER
• Manufacturer (Section D): FH INDUSTRIE; 6 rue nobel; quimper, 29000 ; FR 29000
• MDR Report Key: 9132929
• Report Number: 3003898228-2019-00006
• Device Sequence Number: 2782204
• Product Code: LXH
• UDI-Device Identifier: 03661489501029
• UDI-Public: 03661489501029
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: D114497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/22/2019

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: 250102
• Device Lot Number: G90088-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/30/2019
• 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: Other