MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X55 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5055S
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 march 23, and all nail and screws were removed.Since bone fusion was obtained, it was only removal.".
Additional Manufacturer Narrative
Correction: refer to d4 lot #, section d (device availability), h3-device evaluation.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 traces of normal use but the tip of the screw is 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 indicated on 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 march 23, and all nail and screws were removed.Since bone fusion was obtained, it was only removal.".

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X55 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: 9967470
• Report Number: 0009610622-2020-00155
• Device Sequence Number: 3881511
• Product Code: HSB
• UDI-Device Identifier: 04546540202529
• UDI-Public: 04546540202529
• Combination Product (Y/N): N
• PMA/510(K) Number: K032244
• 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
• 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: 08/31/2023
• Device Model Number: 1896-5055S
• Device Catalogue Number: 18965055S
• Device Lot Number: K0F0566
• 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: 07/03/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 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