MAUDE Adverse Event Report: STRYKER GMBH TIBIAL PLATE, PROXIMAL MEDIAL AXSOS 3 FOR RIGHT TIBIA 4 HOLE / L71MM; PLATE, FIXATION, BONE

Model Number	627734
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the proximal lateral tibia plate and screws were broken.Due to an acute infection, the broken implants, a medial plate and additional screws, were removed and resolved with temporary external fixation placement.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since no evidences that the infection was product related were provided, also there is no allegation against the device in question.The device inspection revealed the following: the visual inspection has shown that the plate has some slight wear marks at the surfaces and the threads, these marks can be traced back to normal use during insertion/extraction.Otherwise is the device in a good condition, no damage that could have contributed to the reported infection or the breakage plate and the screws could be detected.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.No product related issue could be detected.Based on the available information it is not possible to define the root cause of the reported infection, it can be confirmed that the device in question was supplied in unsterile condition to the customer.In this relation following statement from the instructions for use can be pointed out: ¿warning in the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides.¿ if more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the proximal lateral tibia plate and screws were broken.Due to an acute infection, the broken implants, a medial plate and additional screws, were removed and resolved with temporary external fixation placement.

• Brand Name: TIBIAL PLATE, PROXIMAL MEDIAL AXSOS 3 FOR RIGHT TIBIA 4 HOLE / L71MM
• 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: 14465945
• Report Number: 0008031020-2022-00244
• Device Sequence Number: 4507077
• Product Code: HRS
• UDI-Device Identifier: 07613327093889
• UDI-Public: 07613327093889
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 627734
• Device Catalogue Number: 627734
• Device Lot Number: L20330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2017
• 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: 53 YR
• Patient Sex: Male