MAUDE Adverse Event Report: SYMMETRY MEDICAL MANUFACTURING INC MATTA IM CANAL FINDERMANUAL SURGICAL INSTRUMENT FOR GENERAL USE; RASP

Model Number	259807013
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Did a total hip case today with the surgeon and during the case a matta im canal finder broke off in the patients femoral canal.After an hour and a half, we got the broken instrument out of the patients femoral canal.Was surgery delayed due to the reported event? yes.If yes, number of minutes: an hour and a half.

• Brand Name: MATTA IM CANAL FINDERMANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Common Device Name: RASP
• Manufacturer (Section D): SYMMETRY MEDICAL MANUFACTURING INC; 486 w 350 n; warsaw IN 46582
• Manufacturer (Section G): SYMMETRY MEDICAL MANUFACTURING INC; 486 w 350 n; warsaw IN 46582
• Manufacturer Contact: jeff foster ; 486 w 350 n; warsaw, IN 46582 ; 5742678700
• MDR Report Key: 16713495
• Report Number: 3004776227-2023-02100
• Device Sequence Number: 13855307
• Product Code: HTR
• UDI-Device Identifier: 00847538010664
• UDI-Public: 00847538010664
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: 259807013
• Device Catalogue Number: 10-306-000
• Device Lot Number: SO2051853
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown