MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. SPS Ø3.5X60MM; PLATE, FIXATION, BONE

Catalog Number	338660
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.One of the screws was found to be broken, mid-shaft.The other broken segment was not returned for evaluation.The fracture surface indicates typical signs of a fatigue fracture, having an origination point and spreading across with a rather smooth surface and slight presence of lines of rest, ultimately getting separated instantaneously on the other side.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, it can be said that the screw broke in fatigue manner, reason for which could be multifactorial like overloading due potential non-union or inadequate implant size selection & placement.However, without clinical reports and other patient information, the root cause of the issue could not be determined.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
"it was reported: "patient had a pelvis fx, we used a 7 hole annealed plate to fix the fracture on (b)(6) 2024.No more than 3 weeks later the plate had broken and we had to do a revision/ removal of the stryker product and replace it with another company's product.Prolonged healing incurred".Update: on (b)(6) 2025 1 broken cortex screw observed.
Event or Problem Description
"it was reported: "patient had a pelvis fx, we used a 7 hole annealed plate to fix the fracture on (b)(6) 2024.No more than 3 weeks later the plate had broken and we had to do a revision/ removal of the stryker product and replace it with another company's product.Prolonged healing incurred".Update: on (b)(6) 2025 1 broken cortex screw observed.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.One of the screws was found to be broken, mid-shaft.The other broken segment was not returned for evaluation.The fracture surface indicates typical signs of a fatigue fracture, having an origination point and spreading across with a rather smooth surface and slight presence of lines of rest, ultimately getting separated instantaneously on the other side.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, it can be said that the screw broke in fatigue manner, reason for which could be multifactorial like overloading due potential non-union or inadequate implant size selection & placement.However, without clinical reports and other patient information, the root cause of the issue could not be determined.If any additional information is provided, the investigation will be reassessed.

• Brand Name: CORTEX SCREW S.T. SPS Ø3.5X60MM
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22571294
• Report Number: 0008031020-2025-01280
• Device Sequence Number: 14458483
• Product Code: HRS
• UDI-Device Identifier: 07613327080797
• UDI-Public: 07613327080797
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K050512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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: 338660
• Device Lot Number: X07422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 62 YR
• Patient Sex: Female