MAUDE Adverse Event Report: STRYKER GMBH STANDARD BARREL HIP PLATE, KEYED OMEGA 3 135°, 12 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	597032S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the patient had a second revision of hip fracture with stryker's omega 3 plate.Her primary surgery was a nail and her first revision surgery was a stryker omega 3 plate also.Upon removing the omega 3 plate to put another one in, the surgeon noticed an unusual break.He believed that this could potentially be due to a faulty plate and asked for it to be studied in the lab.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the patient had a second revision of hip fracture with stryker's omega 3 plate.Her primary surgery was a nail and her first revision surgery was a stryker omega 3 plate also.Upon removing the omega 3 plate to put another one in, the surgeon noticed an unusual break.He believed that this could potentially be due to a faulty plate and asked for it to be studied in the lab.".

• Brand Name: STANDARD BARREL HIP PLATE, KEYED OMEGA 3 135°, 12 HOLES
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15769512
• Report Number: 0008031020-2022-00598
• Device Sequence Number: 5057464
• Product Code: KTT
• UDI-Device Identifier: 07613154325139
• UDI-Public: 07613154325139
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K062066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2024
• Device Model Number: 597032S
• Device Catalogue Number: 597032S
• Device Lot Number: D56104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female