MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L16MM; PLATE, FIXATION, BONE

Catalog Number 614616S

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During variax clavicle surgery, the subject two locking screws did not lock to the plate.The insertion angle was within allowable range.Ultimately, the plate was fixed with 3rd locking screw, but couldn't lock firmly.

Manufacturer Narrative

The reported event that during a variax clavicle surgery, two locking screws variax full thread 3.5mm/l16mm did not lock to a superior plate - decreased curvature variax clavicle 7 hole/left, could be confirmed, since the two locking screws variax full thread 3.5mm/l16mm were returned for evaluation and they match the reported failure mode.The 2nd reported ¿locking screw variax full thread 3.5mm/l16mm¿ was received for inspection intact.The head of the screw and the hexagon have scratched surfaces, while the threads, just below the head, are deformed.A functional inspection ¿ inserting the reported screw in the holes of a compatible plate was performed and it was identified that the screw cannot be locked in the plate.However, this is expected, since the threads, are deformed.The inspection protocol was reviewed and did not indicate any deviation from the specifications.Therefore, the reported ¿locking screw variax full thread 3.5mm/l16mm¿ was not delivered deformed, but became like that upon usage.It was also reported that a 3rd locking screw was used, and the plate was locked successfully, but not firmly.Also, the insertion angle was within acceptable range.The plate was not shaped/contoured prior to the insertion of the screws.The screws were inserted manually and no axial pressure was applied.Also, the non-locking event was noticed only in a specific round hole of the plate.A deviation from the proper instructions could have definitely led to a deformation of the devices and the reported no-locking event.Please keep in mind that the instructions for proper use of the devices should be followed at all times.A correct implementation of the appropriate usage instructions, is mandatory for a proper placement of the implants.An improper insertion of the screws, could potentially lead to a negatively affected screw and/or plate design, and most precisely to a deformation of the threads of the screws` head, and/or the inner surface of the plates` hole.As a result, a non-locking effect could have occurred.As per (b)(4), ''ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.However, in the reported case, reasons such as soft tissue trapped in the plate hole or movement of the plate during final tightening, could have led to an increased angulation, and consequently to an improper insertion of the screws into the plate hole.Based on investigation, the root cause was attributed to a user related issue.However, please note that more detailed information about the complaint event as well as the affected devices must be available in order to determine the exact root cause.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.If any further information is provided, the investigation report will be updated.

Event Description

During variax clavicle surgery, the subject two locking screws did not lock to the plate.The insertion angle was within allowable range.Ultimately, the plate was fixed with 3rd locking screw, but couldn't lock firmly.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L16MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7165370
• MDR Text Key: 96594083
• Report Number: 0008031020-2018-00022
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K101056
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 614616S
• Device Lot Number: L40068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2017
• 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): Other
• Patient Age: 18 YR