MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, LEFT,SHORT, 9 HOLES; PLATE, FIXATION, BONE

Catalog Number 54-25374

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Event Description

As reported: "procedure completed successfully in 2017.In 2021, the plate was extracted.This pi is related to a court case pending between the patient and the hospital.".

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.We only received a list of questions from the court indicating a complication with a stryker plate, no information was given on the actual event.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition unknown.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, LEFT,SHORT, 9 HOLES
• Type of Device: 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: 17586028
• MDR Text Key: 321559606
• Report Number: 0008031020-2023-00310
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613154345465
• UDI-Public: 07613154345465
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K040022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 54-25374
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention