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

Model Number 1896-5045S

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

The event could be confirmed, since the screw was found broken during the investigation.The device inspection revealed the following: the locking screw was returned without allegation against the device.However, the visual inspection has shown that the locking screw is broken apart, the fragment with a length of about 20mm was not returned for evaluation.The typical characteristics of a fatigue fracture could be identified at the fracture face.The origin of the crack was at the right corner, there is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture and then we have a shear lip on the left side, where the final fracture occurred.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The locking screw was returned for evaluation and no product related issue could be detected during the investigation.There was no additional information about the event provided, no x-rays and no information about the patient was made available.Therefore the root cause of the breakage cannot be defined.The evaluation of the received screw has shown that fatigue did lead to the breakage of the device.In this relation following statement from the instructions for use (non-active implant) can be pointed out: "these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device." if more information is provided, the case will be reassessed.

Event Description

A gamma nail broke at lag screw hole 4 months post-op.During the inspection one of the returned locking screws was found broken due to fatigue.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X45 MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14163587
• MDR Text Key: 289697859
• Report Number: 0009610622-2022-00141
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: 04546540202505
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 1896-5045S
• Device Catalogue Number: 18965045S
• Device Lot Number: K07873B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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