MAUDE Adverse Event Report: STERIS CORPORATION V.MUELLER; GERZOG MALLET

Model Number	OS1512
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris has requested the device subject of the reported event be sent back for evaluation.Investigation of this event is in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, their gerzog mallet became "dented" and metal "slivers" were observed around the patient.User facility personnel performed an x-ray and confirmed no metal was present in the patient.No report of injury.
Additional Manufacturer Narrative
The gerzog mallet subject of the reported event was returned for evaluation.Evaluation results determined that the mallet had been mishandled (likely dropped).The steel casing was heavily dented and the lead insert was severely deformed.The instructions for use states, "avoid mechanical shock or overstressing the devices." "prior to use, inspect devices to ensure proper function and condition.Do not use devices if they do not satisfactorily perform their intended function or if they have physical damage." steris performed in-service training with user facility personnel on the proper use and operation for the gerzog mallet.No additional issues have been reported.

• Brand Name: V.MUELLER
• Common Device Name: GERZOG MALLET
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 20147858
• Report Number: 1527821-2024-00011
• Device Sequence Number: 14521849
• Product Code: HXL
• UDI-Device Identifier: 10885403102493
• UDI-Public: (01)10885403102493(10)A24XKA
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: OS1512
• Device Catalogue Number: OS1512
• Device Lot Number: (10)A24XKA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown