MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX NARROW COMPRESSION PLATE; PLATE, FIXATION, BONE

Catalog Number UNK_SEL

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "patient brought to theatre for removal of a sydosmosis screw.Plate used was a variax narrow compression plate, screw was through oblong hole.When trying to remove the screw from the oblong hole of a narrow compression plate, it appeared that one side of the screw was beneath the inner part of the plate, whilst one was above, making it impossible to remove.The whole plate had to be removed to be able to remove the screw.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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 device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

As reported: "patient brought to theatre for removal of a sydosmosis screw.Plate used was a variax narrow compression plate, screw was through oblong hole.When trying to remove the screw from the oblong hole of a narrow compression plate, it appeared that one side of the screw was beneath the inner part of the plate, whilst one was above, making it impossible to remove.The whole plate had to be removed to be able to remove the screw.".

• Brand Name: UNKNOWN VARIAX NARROW COMPRESSION PLATE
• Type of Device: 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: 16776478
• MDR Text Key: 313652334
• Report Number: 0008031020-2023-00152
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2023
• 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