MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX FULL THREAD 3.5MM / L12MM; PLATE, FIXATION, BONE

Catalog Number 614612S

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted, ony fragment will be return.

Event Description

It was reported that when the driver was removed from the screw head after the screw was tightened into the plate, a thin metal fragment was found.It is unknown if the fragment comes from the screw thread or from the plate.The devices remained implanted.

Manufacturer Narrative

The reported event that a thin metal fragment was found in the site, when the screwdriver was removed after tightening the «locking screw variax full thread 3.5mm / l12mm» into the «superior lateral plate variax clavicle 3 hole / left», could not be confirmed, since the involved devices were not returned for evaluation and no other evidences were provided.Since the actual ¿superior lateral plate variax clavicle 3 hole / left¿ was not returned, a visual inspection could not be performed.However a potential mishandling of the devices could have led to this event.During tightening, the screw is usually under high tension.Such power, in combination with the existing rotational moves could potentially deform the threads of the screw or the surface of the plates` hole.This deformation could have translated into a complete detachment of the screw`s threads or the hole`s threaded surface, which could result into the appearance of a thin metal piece, as the one reported.As per ifu (v15013): ¿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.[¿] avoid surface damage of implants.[¿] discard all damaged or mishandled implants.¿ nevertheless, it was also reported that both devices ¿ the «locking screw variax full thread 3.5mm / l12mm» and the «superior lateral plate variax clavicle 3 hole / left» ¿ were successfully implanted.Therefore the stripped event of the screws` threads or the plates` threaded surface cannot be confirmed.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 the investigation, the potential root cause would be attributed to a user related issue.However, please note that more detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not received.

Event Description

It was reported that when the driver was removed from the screw head after the screw was tightened into the plate, a thin metal fragment was found.It is unknown if the fragment comes from the screw thread or from the plate.The devices remained implanted.

• Brand Name: LOCKING SCREW VARIAX FULL THREAD 3.5MM / L12MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6555761
• MDR Text Key: 74896933
• Report Number: 0008031020-2017-00291
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 614612S
• Device Lot Number: V50765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• 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