MAUDE Adverse Event Report: STRYKER GMBH 1.7 S VARIAX HAND LOCK PLATE,STRAI,4HOLES; PLATE, FIXATION, BONE

Catalog Number	57-10304
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/13/2023
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
It was reported that the patient had a crush of hand injury that was treated by orif with a 4 hole plate on (b)(6) 2023.The plate broke in situ and was identified by x-rays.The plate was removed on (b)(6)) 2023.
Event or Problem Description
It was reported that the patient had a crush of hand injury that was treated by orif with a 4 hole plate on (b)(6) 2023.The plate broke in situ and was identified by x-rays.The plate was removed on (b)(6) 2023.
Additional Manufacturer Narrative
The reported event could be confirmed, since the received plate is broken as reported.The device inspection revealed the following: there are several impression marks visible, in retrospective it is not possible to define if they were caused during implantation or extraction.The fracture face is on one side strongly deformed with a burr on the outside on both fragments.This damage indicates that the fragments rubbed against each other after the initial breakage on this side of the plate occurred.On this side is also a secondary crack visible next to the breakage.These damages are a typical sign of a fatigue breakage.The previously described rubbing of the fragments can be confirmed under the microscope by the shiny surface and the deformation on one side of the fracture face.This indicates that the plate was first cracked on this side before it broke completely.On the other side, it can be seen that the breakage began with a very fine surface appearance at the hole.The surface then becomes increasingly rough, which corresponds to the faster breaking process due to the by fatigue more and more weakened plate.A review of the device history was not possible because the lot number was not communicated and as the lot number is not marked on the plate due to the small size of the plate.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.During the performed evaluation of the plate no indications of material or manufacturing related problems could be detected.Also no indications of design related problems were found during the investigation.The complaint was forwarded to medical affairs for review with following result: "looking at the x-rays, we see a relatively straight fracture.It is also noted there is limited compression on the fracture after fixation, the fracture line is still clearly visible.I do have to note the quality of the x-rays are not of high quality.The second x-ray suggest that there may have been some callus formation/ bone reaction, although it is hard to be sure, due to the low quality of the shared picture.The available information is limited, we are not aware of the full medical history and the after care and compliance of the patient, in addition only two low quality x-rays in one plane were provided.Based on this information no clear conclusion is possible.However, the event suggest there was a non-union, most probably hypertrophic, probably due to too much movement in the fracture area.This lead to fatigue breakage." no product related issue could be detected.Based on the available information it is not possible to define the root cause of the reported event.More detailed information must be available for a complete assessment.If more information is provided, the case will be reassessed.

• Brand Name: 1.7 S VARIAX HAND LOCK PLATE,STRAI,4HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18275729
• Report Number: 0008031020-2023-00423
• Device Sequence Number: 20567099
• Product Code: HRS
• UDI-Device Identifier: 07613154496280
• UDI-Public: 07613154496280
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K062498
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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: 57-10304
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/13/2024
• 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 Age: 56 YR
• Patient Sex: Male