MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 11G X 15MM OMNICURVE FRACTURE KIT; ARTHROSCOPE

Catalog Number	1032-115-000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the doctor advanced the omincurve into a patient with hard bone.After getting it into the proper position, he went to remove it and it became difficult but he was able to get the introducer out.When he examined it, he noted a 1cm piece of the peek sheath had come off and remained in the patient.It should be noted that the procedure was completed successfully without any patient impact, any medical intervention, a 3 minute surgical delay, and no adverse consequences.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
Event or Problem Description
It was reported that during the procedure, the doctor advanced the omincurve into a patient with hard bone.After getting it into the proper position, he went to remove it and it became difficult but he was able to get the introducer out.When he examined it, he noted a 1cm piece of the peek sheath had come off and remained in the patient.It should be noted that the procedure was completed successfully without any patient impact, any medical intervention, a 3 minute surgical delay, and no adverse consequences.

• Brand Name: 11G X 15MM 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: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19828180
• Report Number: 3015967359-2024-01596
• Device Sequence Number: 18313721
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: (01)07613327554496(17)250222(10)9681728
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/04/2024

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 Catalogue Number: 1032-115-000
• Device Lot Number: 9681728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 11/04/2024
• 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