MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Code Available (3191)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device not returned.

Event Description

It is reported by the surgeon that 3 screws loosened.The patient was revised with a new axsos iii ti plate left femur 4 hole.The procedure was performed without torque and target block.

Manufacturer Narrative

The reported event that a screw was alleged of poor fixation could be confirmed thanks to the provided x-rays.Based on investigation, the root cause was attributed to a device unrelated user/patient issue.The chosen surgical technique, the selected implant type and the patient conditions (poor bone quality) appear not to have provided sufficient support to the condylar fragment.The partial cross-threading observed on the returned screws indicates misalignment.This occurred very likely because drilling for locking screws was performed freehand, with no threaded drill sleeve.It was reported that no aiming block and no torque limiter were used.The former, in combination with the drill sleeve, would have helped correct screw insertion; the latter is to be used for final screw insertion in combination with a screwdriver bit t20 and t-handle in order to ensure adequate screw tightening/locking.The fact that the screws heads do not show significant deformations could be an indicator that they were not tightened with the required torque.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.The instruction for use (v15013 rev n non active implant ifu ot-ifu-105 rev 3) was reviewed: ''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.[.] for your information, avail yourself of the training courses and publications offered (e.G.Operative techniques).[.] contraindications the physician¿s education, training and professional judgement must be relied upon to choose the most appropriate device and treatment.[.] warning implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.'' [original statement(s)] the operative technique (axsos-st-5 en rev 2 axsos 3 ti orif op tech) was reviewed: ''always use the threaded drill sleeve when drilling for locking screws.Freehand drilling will lead to a misalignment of the screw and result in screw cross-threading during insertion.It is essential to drill the core hole in the correct trajectory to facilitate accurate insertion of the locking screws.[.] always perform final tightening by hand using the torque limiter (ref 702750) in combination with a screwdriver bit t20 (ref 705020) and t-handle (ref 702430) [.].This [.] ensures that these screws are tightened to a torque of 4nm.[¿] in order to help facilitate drill sleeve insertion as well as plate handle attachment to the plate, the aiming block may be used.'' [original statement(s)] if the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It is reported by the surgeon that 3 screws loosened.The patient was revised with a new axsos iii ti plate left femur 4 hole.The procedure was performed without torque and target block.

• Brand Name: UNKNOWN SCREW
• Type of Device: IMPLANT
• 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: 5922328
• MDR Text Key: 53736232
• Report Number: 0008031020-2016-00428
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• 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: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 11/14/2016
• 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: 50 YR