MAUDE Adverse Event Report: STRYKER GMBH COMPRESSION PLATE NARROW STRAIGHT VARIAX 2 COMPRESSION 20 HOLES/L246MM; PLATE, FIXATION, BONE

Catalog Number	629520S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "plate rupture without reported trauma.Found in emergency room.Additional medical procedure.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the returned plate found completely broken and only one portion was returned for investigation.Microscopic images of the broken surface show the lines of crest which indicates that the plate has broken in a fatigued manner due to overloading under longer durations.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.Based on the investigation it was determined that the plate broke in a fatigue manner possibly due to overloading.Since no patient medical records and other relevant information are available, an exact root cause could not be determined.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "plate rupture without reported trauma.Found in emergency room.Additional medical procedure.".

• Brand Name: COMPRESSION PLATE NARROW STRAIGHT VARIAX 2 COMPRESSION 20 HOLES/L246MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 19102774
• Report Number: 0008031020-2024-00168
• Device Sequence Number: 7343655
• Product Code: HRS
• UDI-Device Identifier: 07613327303933
• UDI-Public: (01)07613327303933(17)270831(10)K54821
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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 Catalogue Number: 629520S
• Device Lot Number: K54821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 04/13/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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 Sex: Unknown