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

Catalog Number 1032-115-000

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  Injury  

Event Description

It was reported that the sheath from the omni curve became stuck and broke off during retraction.A biopsy device was used to cut the sheath and the piece was removed.It should be noted the procedure was successful with no patient impact, no clinically significant delay, or adverse consequences.

Manufacturer Narrative

H3 other text : discarded by customer.

• Brand Name: 11G X 15MM OMNICURVE FRACTURE KIT
• Type of Device: 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: 17956188
• MDR Text Key: 325903487
• Report Number: 3015967359-2023-02127
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327554496
• UDI-Public: 07613327554496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162062
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1032-115-000
• Device Lot Number: 9026924
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention