MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN VARIAX SCREW; SCREW, FIXATION, BONE

Catalog Number UNK_SEL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Non-union Bone Fracture (2369); Implant Pain (4561)

Event Date 12/22/2022

Event Type  Injury  

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 in a supplemental report.

Event Description

It was reported that the patient complained of pain.Bone fusion failure and screw backout were found.It was determined that there was no infection, but there was a suspicion of metal allergy.An x-ray was received that showed additional screws that have been revised.Additional screws to be reported due to suspicion of metal allergy reported.

Event Description

It was reported that the patient complained of pain.Bone fusion failure and screw backout were found.It was determined that there was no infection, but there was a suspicion of metal allergy.An x-ray was received that showed additional screws that have been revised.Additional screws to be reported due to suspicion of metal allergy reported.

Manufacturer Narrative

Please note correction to h6 (device code).The reported event could be confirmed, since an x-ray was provided which matches the alleged failure mode.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.An x-ray was provided which was presented to our health care professional for evaluation, and a question about the most likely reason for the screw backout was asked, to which the medical expert replied: ¿with the limited information available it is almost impossible to give a root cause.The first cause could be improper locking of the locking screws, or improper use of the locking screws (outside of the cone/ angle in which the screws can be properly locked.Second could be related to the construction being unstable, which may have caused too much movement of the parts, which lead to screw movement and loosening.However as said, based on the available information an actual cause cannot be determined.¿ 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.

• Brand Name: UNKNOWN VARIAX SCREW
• Type of Device: SCREW, 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: 16329476
• MDR Text Key: 309125580
• Report Number: 0008031020-2023-00061
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• 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
• Patient Age: 74 YR
• Patient Sex: Male