MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X47,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5047S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
As reported: "after fixation of t2gtn, the distal screw broke." additionally reported: "the revision was made on (b)(6), and all nail and screws were removed.Since bone fusion was obtained, it was only removal.".
Additional Manufacturer Narrative
Due to the current covid-19 pandemic, it was not possible to inspect the returned device due to facility access restrictions.The investigation will be reassessed as soon as the restrictions are lifted.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.As the event stated there was a proper consolidation of the fracture, the most likely cause of breakage would be overloading of the screw as the patient was also slightly overweight and also the fact that both the screws broke, it gives a clear indication towards overloading.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "after fixation of t2gtn, the distal screw broke." additionally reported: "the revision was made on march 23, and all nail and screws were removed.Since bone fusion was obtained, it was only removal.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received screw was found to be broken from the mid-shaft region.The appearance of the breakage surface suggests that the screw broke in a fatigue manner.This is evident by the waves or lines of rest originating from one end, gradually spreading towards the other end and breaking instantaneously there.The threads of the screw at the distal end exhibits deformation.The threads are absolutely splayed, most likely due to improper insertion during the surgery.But this has no major impact on the breakage of the screw.The tip of the screw is also substantially deformed, plastically.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.Based on the above investigation, the root cause of the failure is patient related.The screw broke in a fatigue manner due to possible overloading as the patient is clearly overweight.The fixation was achieved as intended and no user related or manufacturing related deficiencies were found.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "after fixation of t2gtn, the distal screw broke." additionally reported: "the revision was made on (b)(6) and all nail and screws were removed.Since bone fusion was obtained, it was only removal.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X47,5 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; DE D-24232
• MDR Report Key: 9965565
• Report Number: 0009610622-2020-00151
• Device Sequence Number: 11399563
• Product Code: HSB
• UDI-Device Identifier: 04546540382351
• UDI-Public: 04546540382351
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2024
• Device Model Number: 1896-5047S
• Device Catalogue Number: 18965047S
• Device Lot Number: K0BB024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/19/2020; 07/03/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/15/2020; 07/30/2020
• 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: 18 YR
• Patient Weight: 87