MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ADVANCED LOCKING SCREW IMN SCREWS Ø5X75MM; SCREW, FIXATION, BONE

Model Number	2361-5075S
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	02/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient was brought back to revise an interlocking screw that was backing out and take out antibiotic spacer.Minifrag and small frag plating, along with bone grafting were used during the revision.
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could be confirmed, since the dislocation of the advanced locking screw is visible on the received x-rays.The device inspection revealed the following: the visual inspection of the received screw has shown that the thread flanks of the screw are damaged, there are clearly visible stress marks all over.The anodized layer is worn away at all damages, which indicates that the damages were caused post-manufacturing.However, afterwards it cannot be defined anymore if these damages occurred during implantation, in-situ or during extraction.The involved nail was not returned for evaluation, therefore it cannot be defined if these damages did contribute to the dislocation of the screw in interaction with the nail.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 complaint was forwarded to medical affairs for review with following feedback: "the x-ray shows a devastating supracondylar fracture with involvement of the articular surface and the patella.There is a very large metaphyseal defect that has been laterally supported with bone cement.While there is the retrograde nail introduced intracondylar, small fragment osteosynthesis has been performed in the medial and lateral condyle and medially at the transition of the diaphysis to the upper metaphysis.In the ap-view we can also see, that the joint line is far from being horizontal with the medial condyle being further distal then the lateral, a finding which suggests a lack of stability laterally, here.The overall bone quality appears alarmingly poor.With the given combination of osteosynthesis (nail, plate, free screws, bone cement) all defects have been addressed from a surgical perspective, the postoperative mobilization with touch down weight bearing seems adequate.In conclusion, it can be said that there are strong patient related factors: poor bone quality and the disastrous fracture pattern.Both have contributed to the instability of the whole-more or less loose-articular fragment which is almost without any bony connection to the shaft portion of the bone.This instability led to a minimal tilting movement that was transmitted to the screw and ended in the migration of the screw." based on investigation, the root cause was attributed to a patient related issue.The dislocation of the locking screw was caused by the above described patient related factors.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient was brought back to revise an interlocking screw that was backing out and take out antibiotic spacer.Minifrag and small frag plating, along with bone grafting were used during the revision.

• Brand Name: ADVANCED LOCKING SCREW IMN SCREWS Ø5X75MM
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16458559
• Report Number: 0009610622-2023-00070
• Device Sequence Number: 2343856
• Product Code: HWC
• UDI-Device Identifier: 07613327381467
• UDI-Public: 07613327381467
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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 Model Number: 2361-5075S
• Device Catalogue Number: 23615075S
• Device Lot Number: K0E9EE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 86 KG