MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965040S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Still implanted.
Event or Problem Description
On (b)(6) 2018, an elongated gamma3 nail was placed in a (b)(6) year-old female patient via an open reposition procedure.Ten days after surgery the patient could start carefully load her injured leg again.She didn't use crutches nor rollator.On (b)(6) 2019, a control x-ray showed that the distal locking screw was broken.Surgeon decided not to do anything about it in order to get more compression in the fracture site.The nail provided dynamization.Hardly any callus formation was visible.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure.Device inspection revealed the following: through the visual inspection of the reported locking screw, it was found to be completely broken approx.Midshaft into two fragments.All breakage surfaces of broken fragments show features of a fatigue fracture.Plastic deformation was not found.The thread flanks of the locking screw are significantly flattened around the bottom region.This type of damage found at the threads indicate high axial load application, as well.Based on investigation, the root cause was attributed to a user related issue.The failure was caused due to sub-optimal procedure followed by the surgeon during fixation of the fracture.Although the nail was placed in the correct position but was done without restoring the ventral and medial defect leading to an unstable fixation.There are visible signs of a fatigue fracture in the screw which was basically caused due to this unstable fixation.Proper reduction wasn¿t achieved thereby, whole of the weight bearing ended up only on the nail and the screws.As a result of which the screw broke first when the load value crossed the screw¿s ultimate fatigue strength.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
On (b)(6) 2018 an elongated gamma3 nail was placed in a 72-year-old female patient via an open reposition procedure.Ten days after surgery the patient could start carefully load her injured leg again.She didn¿t use crutches nor rollator.On (b)(6) 2019 a control x-ray showed that the distal locking screw was broken.Surgeon decided not to do anything about it in order to get more compression in the fracture site.The nail provided dynamization.Hardly any callus formation was visible.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X40 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
• MDR Report Key: 8695307
• Report Number: 0009610622-2019-00486
• Device Sequence Number: 2072919
• Product Code: HSB
• UDI-Device Identifier: 04546540202499
• UDI-Public: 04546540202499
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 18965040S
• Device Lot Number: K02D418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 74