MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM; IMPLANT

Catalog Number 18965050S

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device remains implanted.

Event Description

The customer reported that 2 x proximal t2 5mm locking screws implanted on (b)(6) 2018 backed out the patient will have the screw re inserted during an upcoming spinal surgery while he¿s asleep.

Event Description

The customer reported that 2 x proximal t2 5mm locking screws implanted on (b)(6) 2018 backed out the patient will have the screw re inserted during an upcoming spinal surgery while he¿s asleep.

Manufacturer Narrative

The reported event that locking screw, fully threaded t2 tibia ø5x50 mm was alleged of issue (implant migration) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.The nylon bushing and the crosslocks thread of the nail improve the holding strength of the proximal locking screws and helps avoid screw back out and also stop screw toggle.If the proximal locking holes have no or a damaged nylon bushing, the screws have no resistance against back out.Potential reasons for no or damaged nylon bushings can be: ¿ if a wrong drill was used during surgery the thread and the nylon bushing will be damaged.The op-technique refers that a 3.5mm drill should be used for the hole drilling.If the user takes a 5mm drill the cutting edges damage the thread of the hole and the nylon bushing.The result is a lower fixation of the locking screw and could end in screw motion.¿ both cortexes were drilled ¿ the op-tech warns to drill the lateral cortex, only.¿ drilling without drill guiding sleeve ¿ using blunt or damaged drill ¿ high forces applied to the target device during drilling ¿ eventually leading to unintended distortion in the system of drill, sleeve, target device and nail.Reasons for screw migration could be also due to an insufficiently tightened end cap (ensures axial stability) or release of the end cap (due to decreasing ¿ caused by advanced bone healing ¿ but repeated load) in combination with a kind of ¿rollover¿ of the locking screw caused by the patient¿s motion.Screw back out can be contributed by the patient¿s condition.The suggested age of the patient (72 years) implies that the bone can be of poor quality.This condition may lead to insufficient / unsafe screw placement ¿ even if the nail is promoted having securing features (pe-inlays) against screw back out.An interaction between poor bone condition and reported pendular exercises could have resulted in screw loosening.With available information a deficiency of the humeral nail and locking screws could not be verified a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X50 MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7542284
• MDR Text Key: 109218617
• Report Number: 0009610622-2018-00213
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 18965050S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR