MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G X 20MM OMNICURVE FRACTURE KIT; ARTHROSCOPE

Model Number	1032-120-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the handle broke off when removing the peek sheath.It should be noted, that the procedure was completed successfully.There was no patient impact.Medical intervention was not needed.There was no delays in the procedure.And no adverse events were reported to the patient.
Event or Problem Description
It was reported that the handle broke off when removing the peek sheath.It should be noted that the procedure was completed successfully, there was no patient impact, medical intervention was not needed, there was no delays in the procedure, and no adverse events were reported to the patient.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: 11G X 20MM OMNICURVE FRACTURE KIT
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 16930518
• Report Number: 3015967359-2023-01117
• Device Sequence Number: 17822490
• Product Code: HRX
• UDI-Device Identifier: 07613327554663
• UDI-Public: 07613327554663
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 1032-120-000
• Device Catalogue Number: 1032-120-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown