MAUDE Adverse Event Report: INNOMED, INC. INNOMED SURE GRIP SOFT TISSUE GRASPER (PITUITARY RONGEUR); TRAY, SURGICAL, INSTRUMENT

Lot Number	(10) 0122GH
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Pt had reverse total shoulder surgery.Surgery was completed and patient taken to pacu.The instruments for the case were taken to decontamination, where the spd employee washing the instruments noted a piece missing from a pituitary ronguer.Physician responded that he saw the x-ray and the piece of metal; noted shouldn't be a problem now.He plans to re-x-ray at his postop appointment to see if the piece had moved which was determined to be a piece of the pituitary ronguer.The patient was sent home and it appears the small piece left in shoulder should not be a problem but will be monitored on future appointment.Fda safety report id# (b)(4).

• Brand Name: INNOMED SURE GRIP SOFT TISSUE GRASPER (PITUITARY RONGEUR)
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): INNOMED, INC.; savannah GA 31404
• MDR Report Key: 15893712
• Report Number: MW5113547
• Device Sequence Number: 5914528
• Product Code: FSM
• UDI-Device Identifier: 00840277105943
• UDI-Public: (01)00840277105943
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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 Lot Number: (10) 0122GH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White