MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965045S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported that 2 x proximal t2 5 mm 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 or Problem 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.
Additional Manufacturer Narrative
The reported event that locking screw, fully threaded t2 tibia ø5x50 mm was alleged of issue k-230 (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 Ø5X45 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7707349
• Report Number: 0009610622-2018-00362
• Device Sequence Number: 2542146
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: 04546540202505
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 18965045S
• Device Lot Number: K0326C2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR