MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L32MM; SCREW, FIXATION, BONE

Catalog Number	657432
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/25/2024
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
The customer reported the following: "i have been informed of an incident that occurred during the installation of a variax plate ref.(b)(4): a fragment of plate detached itself in the form of a thread during screwing, causing a wound on the surgeon's right hand.An accident due to exposure to blood and a work-related accident were reported.".
Additional Manufacturer Narrative
Corrections: please refer to sections d2a and d2b.The reported event could be confirmed, since the detached fragment could be confirmed as described in the event description.The device inspection revealed the following: the bone screw and as well the metal chip were returned for evaluation.The t10 recess of the screw has wear marks with slight deformations that point in clockwise and counterclockwise direction, which indicates that the screw was exposed to higher torsional loads in both directions during insertion and extraction.A microscopic inspection was performed, during the inspection it could be clearly confirmed that the returned metal chip was peeled off from the screw thread flanks.The peeling off started at the self-cutting flute and did end in the middle of the shaft.The peeled off surface is homogenous, which indicates material conformity.The shiny surface next to the peeled off surface indicates an excessive metallic contact.A very excessive metallic contact is also indicated at the forefront of the screw, before the thread flanks start.In retrospective it cannot be defined if this contact was with the plate or any other device, e.G.A screw that was already inserted.But the same excessive contact did lead to the damage at the thread flanks.At all overserved damages is the anodized layer not present anymore, which indicates that they were caused post-manufacturing.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.Based on investigation, the root cause was attributed to a use related issue.The event was caused by an unintended excessive contact with another device during screw insertion.If more information is provided, the case will be reassessed.
Event or Problem Description
The customer reported the following: "i have been informed of an incident that occurred during the installation of a variax plate ref.629284: a fragment of plate detached itself in the form of a thread during screwing, causing a wound on the surgeon's right hand.An accident due to exposure to blood and a work-related accident were reported.".

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L32MM
• Common Device Name: 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: 19792460
• Report Number: 0008031020-2024-00271
• Device Sequence Number: 12534803
• Product Code: HWC
• UDI-Device Identifier: 07613327074048
• UDI-Public: (01)07613327074048(10)G35789
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: Health Professional
• Device Catalogue Number: 657432
• Device Lot Number: G35789
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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: Other
• Patient Sex: Unknown