MAUDE Adverse Event Report: SYMMETRY MEDICAL MANUFACTURING, INC HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	270904001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Blade did not fit in handle.

• Brand Name: HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYMMETRY MEDICAL MANUFACTURING, INC; 486 west 350 north; warsaw IN 46582
• Manufacturer Contact: michael parrish ; 486 west 350 north; warsaw, IN 46582 ; 5742678700
• MDR Report Key: 16922010
• Report Number: 3004776227-2023-02347
• Device Sequence Number: 6920619
• Product Code: LXH
• UDI-Device Identifier: 00847538001051
• UDI-Public: 00847538001051
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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: 270904001
• Device Catalogue Number: 10-020-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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