MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1896-5065S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	02/04/2021
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.
Event or Problem Description
As reported: "in (b)(6) 2018, the patient underwent osteosynthesis surgery with an intramedullary nail for a diaphyseal fracture of the left tibia.Subsequently, the fracture evolved towards a progressive consolidation, whereby the finding of a break in the most proximal screw of the 2 distal locking screws of the nail.During the last outpatient checks, the patient complained of intolerance to the means of synthesis, which is why, on (b)(6) 2021, he underwent complete removal of the nail and screws (duration of the procedure: 1 hour and 15 minutes)".
Event or Problem Description
As reported: "in (b)(6) 2018, the patient underwent osteosynthesis surgery with an intramedullary nail for a diaphyseal fracture of the left tibia.Subsequently, the fracture evolved towards a progressive consolidation, whereby the finding of a break in the most proximal screw of the 2 distal locking screws of the nail.During the last outpatient checks, the patient complained of intolerance to the means of synthesis, which is why, on (b)(6) 2021, he underwent complete removal of the nail and screws (duration of the procedure: 1 hour and 15 minutes)".
Additional Manufacturer Narrative
The reported event, was confirmed on x-rays.Review of device history, labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of material, manufacturing or design related problems were found during the document review.According to received information the locking screw had broken after an implantation period of more than 2.5 years.During this time the bone fracture had completely healed and no further implants had broken.Subsequently, all implants were removed during explantation of the screw fragments.The labelling already informs about that the implant is intended for temporary bone fixation.In the event of a delay in bone consolidation, or if such consolidation does not take place, or if explantation is not carried out, complications may occur, for example fracture or loosening of the implant or instability of the implant system.The implants had fulfilled the task of temporary bone stabilization.Based on available information a deficiency of the product could not be verified.The event was caused by patient¿s conditions.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA 5X40 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; GM D-24232
• MDR Report Key: 11499244
• Report Number: 0009610622-2021-00423
• Device Sequence Number: 14417528
• Product Code: HSB
• UDI-Device Identifier: 04546540202543
• UDI-Public: 04546540202543
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 05/31/2023
• Device Model Number: 1896-5065S
• Device Catalogue Number: 18965040S
• Device Lot Number: K034F61
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/24/2021
• 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