MAUDE Adverse Event Report: STRYKER GMBH 6.5MM CENTER SCREW - 32M M; SCREW, FIXATION, BONE

Model Number	5573-6532
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Post op xray shows broken center screw and not broken but pulled through baseplate.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Device disposition is unknown.
Event or Problem Description
Post op xray shows broken center screw and not broken but pulled through baseplate.
Additional Manufacturer Narrative
Please note the corrections regarding the d9/h3, g1 manufacturing site for devices, h6 (method & results code): the reported event was confirmed based on the observations made during the investigation.The device inspection revealed the following: the returned center screw is broken in two in the middle of the thread, both fragments were returned.There is evidence of a gradual ductile fracture, based on the deformation observed on the broken surface.Dimensional inspection showed that the dimeter of the center screw is within specification.Note: the returned baseplate, glenosphere and the upper half of the center screw are still assembled and could not be disassembled by hand.Disassembling was not necessary as it would not bring more information to the investigation.The baseplate and the glenosphere are concomitant products and did not contribute to the reported breakage.Having the upper part of the screw would not bring more information on the implant, since the lot #, for instance, is not marked on the device.The returned humeal cup (concomitant product) is highly worn out, giving indication of important loads applied to the implant, possibly during a long period of implantation.Despite the returned devices and the observations made, it was not possible to determine the root cause of the screw breakage.More information such as the lot number of the center screw; x-rays; patient history and behavior following the implantation and the period of implantation are necessary for a deeper investigation.A review of the device history was not possible because the lot number was not communicated.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.If any additional information is provided, the investigation will be reassessed.

• Brand Name: 6.5MM CENTER SCREW - 32M M
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; postfach; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16141717
• Report Number: 0008031020-2023-00017
• Device Sequence Number: 6529550
• Product Code: HWC
• UDI-Device Identifier: 07613327098839
• UDI-Public: 07613327098839
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 03/15/2023

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 Model Number: 5573-6532
• Device Catalogue Number: 5573-6532
• Device Lot Number: UNKNOWN
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male